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Clinical Trial Title : A prospective, multicentric, open label clinical study to evaluate safety and performance of Melange BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System for use as an ajdjunct to Percutaneous Transluminal Renal Angioplasty of atherosclerotic de novo or restenotic lesion of the renal artery. (Protocol No. : Melange BRS – 1)

Indication : Renal Angioplasty

Dr. Vimal Someshwar Interventional Radiology III National Ongoing

Clinical Trial Title : A Phase 2 dose- range finding 12-week, double-blind, randomized, parallel group study to evaluate safety and efficacy of GRC 27864 in patients with moderate osteoarthritis pain. (Protocol No. : GRC 27864-201)

Indication : Osteoarthritis

Dr. Sunil Kumar Singh Centre for Bone & Joint II National Ongoing

Clinical Trial Title : A 52-Week Multicenter, Randomized, Open-Label, Parallel-Group Study Evaluating the Efficacy and Safety of Ixekizumab versus Adalimumab in Patients with Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naïve. (Protocol No. : I1F-MC-RHCF)

Indication : Psoriatic Arthritis

Dr. Jyotsna Oak Internal Medicine 3b/4 International Ongoing

Clinical Trial Title : A randomized, double-blind, active control, multi center study to evaluate the efficacy at week 52 of subcutaneously administered secukinumab monotherapy compared with subcutaneously administered adalimumab mono therapy in patients with active psoriatic arthritis. Protocol No.: (CAIN457F2366)

Indication : Psoriatic Arthritis

Dr. Jyotsna Oak Internal Medicine III International Ongoing

Clinical Trial Title : Hospital Based Cancer Registry in Sources of Registrations of already existing Population Based Cancer Registry at Bengaluru, Chennai, Delhi, Mumbai and Kolkata.

Indication : All types of Cancer

Dr. Rajesh Mistry Centre for Cancer Not Applicable National Ongoing

Clinical Trial Title :

Indication : Critical Limb Ischemia

Dr. Vimal Someshwar Interventional Radiology I/II National Ongoing

Clinical Trial Title : A prospective, 16 week, non-interventional, observational study to evaluate safety and tolerability in patients with severe dementia of a Alzheimer's type exposed to rivastigmine (Exelon) 15 cm2 transdermal patch. (Protocol No. : CENA713DIN01)

Indication : Alzheimer's Disease

Dr. Annu Aggarwal Centre for Neurosciences Registry National Ongoing

Clinical Trial Title : A Phase III, randomized, double-blind, placebo controlled multi-center study of subcutaneous secukinumab (150 mg and 300 mg) in prefilled syringe to demonstrate efficacy (including inhibition of structural damage), safety, and tolerability up to 2 years in subjects with active psoriatic arthritis (FUTURE 5). (Protocol No. : CAIN457F2342)

Indication : Psoriatic Arthritis

Dr. Jyotsna Oak Internal Medicine III International Ongoing

Clinical Trial Title : A prospective, open label and multicentric clinical study to evaluate safety and performance of CREDENCE™ BRS Sirolimus Eluting BioResorbable Peripheral Scaffold System in subjects with de novo native peripheral artery lesions. (Protocol No. : CREDENCE™ BRS – 1)

Indication : Critical Limb Ischemia

Dr. Vimal Someshwar Interventional Radiology I/II National Ongoing

Clinical Trial Title : International multicenter randomized double blind phase III trial comparing safety and efficacy of BCD-021 (CJSC BIOCAD, Russia) and paclitaxel + carboplatin to Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) and paclitaxel + carboplatin in inoperable or advanced no squamous non-small-cell lung cancer patients. (Protocol No. : BCD-021-02)

Indication : Non Small Cell Lung Cancer

Dr. Sandeep Goyle Centre for Cancer III International Ongoing

Clinical Trial Title : A double blind, double-dummy, randomized, prospective, two arm, parallel, multicenter, Phase IV clinical trial to evaluate efficacy and safety of Gabapin NT (fixed-dose combination of gabapentin and nortriptyline) in comparison with Gabapentin in patients with neuropathic pain.(Protocol No. : 0555-17)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: Intas Pharmaceuticals Ltd
  • c) Purpose of Study: The purpose of this trial is to evaluate the safety and effectiveness of the Sponsor’s test formulation of GABAPIN NT tablet after oral administration and compare it with reference Capsule Gabapentin 400 mg and establish superiority in patients suffering from neuropathic pain. GABAPIN NT tablet is fixed dose combination of gabapentin 400 mg and nortriptyline 10 mg manufactured by Intas pharmaceuticals Limited. This formulation is expected to provide benefits to patients suffering from neuropathic pain.
  • d) Key Inclusion-Exclusion criteria

    Inclusion Criteria

    • Patients of either gender between 18 and 65 years
    • Diagnosis of chronic neuropathic pain by investigator before at least 3 months of Screening

    Exclusion criteria

    • Any major organ system disease, cardiovascular autonomic neuropathy, sedation or ataxia due to concomitant drugs or other cause.
    • Urinary symptoms attributable to benign prostatic hypertrophy in male participants.
  • Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

  • e) CTRI URL link with the above information http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=20982&EncHid=&userName=Kokilaben

Indication : Neuropathic Pain

Dr. Abhishek Srivastava Centre for Physical Medicine & Rehabilitation IV National Ongoing

Clinical Trial Title : A randomized, double-blind, placebo controlled, 3- part, adaptive design, multicenter 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis (NASH). (Protocol No. : CLJN452A2202)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: Novartis India Pvt Ltd
  • c) Purpose of Study: The purpose of the study is to learn whether it is safe to treat patients who have NASH with the study drug tropifexor. The study will also learn about the effects of different doses of tropifexor on markers of liver swelling in patients with NASH.
  • d) Key Inclusion-Exclusion criteria

    Inclusion Criteria

    • Male and female patients 18 years or older
    • Adequate liver biopsy sample for evaluation by Central Reader to confirm Histologic evidence of NASH based on liver biopsy obtained during the Screening period or within 6 months before randomization with a diagnosis consistent with NASH, fibrosis level F2 or F3, and no diagnosis of alternative chronic liver diseases.

    Exclusion criteria

    • History of hypersensitivity to the study drug or its excipients or to drugs of similar chemical classes
    • Previous exposure to FXR agonists (including tropifexor)
  • Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

  • e) CTRI URL link with the above information http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=19905&EncHid=&userName=Kokilaben

Indication : Non Alcoholic Steatohepatitis

Dr. Gaurav Mehta Centre for Transplant II National Ongoing

Clinical Trial Title : A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients with Low Tumor Burden Follicular Lymphoma. (Protocol No.: AGB002)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: Archigen Biotech Limited
  • c) Purpose of Study: The study drug being assessed in this study is an investigational medication called SAIT101, which is a proposed biosimilar of rituximab. This means that it is biologically similar to a medication called rituximab (also called Rituxan® or MabThera®) that has already been approved by regulatory agencies in several countries for the treatment of non-Hodgkin’s lymphoma. LTBFL (low tumor burden follicular lymphoma) is known as one type of non-Hodgkin’s lymphoma. The purpose of the study is to evaluate how well the study drug works and how safe it is, compared to rituximab (MabThera®, the rituximab product approved in the European Union).
  • d) Key Inclusion-Exclusion criteria

    Inclusion Criteria

    • Male or female patients aged at least 18 years
    • Histologically-confirmed, without B symptoms, Ann Arbor stage II to IVA NHL Exclusion criteria
    • Previous treatment with any chemotherapy and/or rituximab or other monoclonal antibody.
    • Prior radiotherapy completed < 28 days before study enrollment
  • Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

  • e) CTRI URL link with the above information http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19121&EncHid=&userName=

Indication : Follicular Lymphoma

Dr. Sandeep Goyle Centre for Cancer III International Ongoing

Clinical Trial Title : A Phase III, Open-Label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab compared with Chemotherapy in Patients with Treatment-Naïve Advanced or Recurrent (Stage IIIB not amenable for multimodality treatment) or Metastatic(Stage IV) Non-Small Cell Lung Cancer who are deemed unsuitable for Platinum-Containing therapy. (Protocol No.: MO29872)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor : Roche Products India Pvt Ltd
  • c) Purpose of Study in layman term for patient’s understanding The purpose of this study is to compare the effects, good or bad, of atezolizumab versus chemotherapy on patient and his/her disease to find out, which is better. In this study, patient will get either atezolizumab or a chemotherapy drug (study doctor will choose one of the following: vinorelbine or gemcitabine). If patient gets atezolizumab, he/she may be treated for as long as he/she benefit from this study drug, even if tumor assessments show that his/her tumors are growing. Atezolizumab has been approved in the USA for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy, but it has not been approved in patients who cannot receive any cisplatin and carboplatin chemotherapy, as it is in this case. If patient gets a chemotherapy drug that study doctor has chosen, he/she will be treated as per local practice.
  • d) Key Inclusion-Exclusion criteria in lay language

    Inclusion Criteria

    • Male or female, age ≥ 18 years
    • Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC
    • No sensitizing EGFR mutation (L858R or exon 19 deletions) or ALK fusion oncogene detected
    • No prior systemic treatment for advanced or recurrent (Stage IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC

    Exclusion Criteria

    • History of autoimmune disease
    • Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only

    Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

Indication : Non Small Cell Lung Cancer

Dr. Rajesh Mistry Centre for Cancer III International Ongoing

Clinical Trial Title : A Prospective, Open-label, Phase 4 Study to Evaluate the Safety of Pembrolizumab (KEYTRUDA®) in Subjects with Unresectable or Metastatic Melanoma or PD-L1 positive Non-small Cell Lung Cancer (NSCLC) in India (Keynote-593).(Protocol No.: MK-3475-593)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
  • c) Purpose of Study :

    The purpose of this study is to test the safety of the study drug, pembrolizumab, in patients with:

    • Melanoma that cannot be removed completely by surgery or has spread to other organs.
    • Non-small cell lung cancer (NSCLC) that cannot be removed completely by surgery or has spread to other organs.
  • d) Key Inclusion-Exclusion criteria

    Inclusion Criteria

    • Male/female subjects who are of at least 18 years of age with a histologically confirmed diagnosis of unresectable or metastatic melanoma, and NSCLC subjects who are either untreated or have experienced disease progression after a platinum containing systemic therapy

    Exclusion Criteria

    • NSCLC Subjects only (1st Line, 2nd Line, and Beyond Subjects): Has a tumor specimen that is not evaluable for PD-L1 expression by the central laboratory
  • Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

Indication : Non Small Cell Lung Cancer

Dr. Sewanti Limaye Centre for Cancer IV International Ongoing

Clinical Trial Title : An Open Label, Single Arm, Multicentre Study to Assess the Clinical Efficacy and Safety of Lynparza (Olaparib) Tablets Maintenance Monotherapy in Platinum Sensitive Relapsed Ovarian Cancer Patients who are in Complete or Partial Response Following Platinum based Chemotherapy (L-MOCA)(Protocol No.: D0816C00016)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: Astrazeneca Pharma India Limited
  • c) Purpose of Study: This study is designed to see if study medication, olaparib, as maintenance monotherapy is effective and safe in treating platinum sensitive relapsed epithelial ovarian, fallopian tube or primary peritoneal cancer. “Platinum sensitive relapsed” means that patient has received and are responding to platinum containing chemotherapy (e.g., Carboplatin), and patient’s cancer developed recurrence >6 months after completion of the platinum containing chemotherapy. Most patients only take regular follow up observation after completing the requisite number of cycles of chemotherapy, because chemotherapy can cause neurological, renal and haematological toxicity and is not suitable for future maintenance treatment. Several studies have confirmed olaparib could reduce disease progression risk and extend overall survival with well tolerability as maintenance monotherapy after chemo.
  • d) Key Inclusion-Exclusion criteria

    Inclusion Criteria

    • Age 18 years or over
    • Patients with platinum sensitive relapsed high grade (serous or endometrioid) epithelial ovarian cancers (including primary peritoneal and/or fallopian tube cancer) Platinum sensitive disease is defined as disease progression ≥ 6 months after completion of their last dose of platinum based chemotherapy

    Exclusion criteria

    • Participation in another clinical study with an investigational product during the most recent chemotherapy course
    • Any previous treatment with PARP inhibitor, including olaparib
  • Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

Indication : Ovarian Cancer

Dr. Sewanti Limaye Centre for Cancer III International Ongoing

Clinical Trial Title : A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Given Concurrently with Platinum-basedChemoradiation Therapy in Patients with Locally Advanced, UnresectableNon-small Cell Lung Cancer (Stage III) (Protocol No.: D933KC00001)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: AstraZeneca AB
  • c) Purpose of Study: The purpose for the study is to find more effective treatment for Stage III NSCLC.

    AstraZeneca AB is doing this research to find out if the experimental medication called Durvalumab will work and be safe for the treatment of Stage III NSCLC. Durvalumab is approved by some health authorities for advanced bladder cancer and is in the process of early approval for Stage III NSCLC in some countries.

  • d) Key Inclusion-Exclusion criteria

    Inclusion Criteria

    • Age 18 years or over
    • Histologically or cytologically documented NSCLC who present with locally advanced, unresectable (Stage III) disease Exclusion criteria
    • History of allogeneic organ transplantation
    • Active or prior documented autoimmune or inflammatory disorders
    • Patients with vitiligo or alopecia

    Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

Indication : Non Small Cell Lung Cancer

Dr. Sewanti Limaye Centre for Cancer III International Ongoing

Clinical Trial Title : A Randomized, Open-label, Multi-center Phase III Study of Durvalumab and Tremelimumab as First-line Treatment in Patients with Unresectable Hepatocellular Carcinoma (HIMALAYA). (Protocol No. : D419CC00002)

  • a) Contact Details of study team: Dr Ambreen L Khan: +91 8128468698
  • b) Name of Sponsor: Astrazeneca Pharma India Limited
  • c) Purpose of Study : Patient to take part in this clinical research study have been diagnosed with a type of liver cancer (hepatocellular carcinoma) that cannot be removed by surgery (unresectable) or treated locally and have never had treatment for liver cancer with drugs prescribed by cancer doctor and with drugs that act in a similar way to durvalumab and tremelimumab. This research study is designed to see if the new anti-cancer drug durvalumab given by itself or with tremelimumab will work better than the drug sorafenib (the standard-of-care treatment) in treating this type of cancer. It will also determine whether these drugs cause any side effects and will compare them to sorafenib.
  • d) Key Inclusion-Exclusion criteria in lay language

    Inclusion Criteria

    • Age ≥ 18 years and Body weight > 30 kg at the time of screening
    • Confirmed HCC based on histopathological findings from tumor tissues
    • Must not have received prior systemic therapy for HCC
    • Must not be eligible for locoregional therapy for unresectable HCC Exclusion Criteria
    • No portal vein thrombosis
    • Previous study drug(s) assignment in the present study
    • Have received an investigational product within 28 days prior to the first dose of study drug(s).
    • Concurrent enrollment in another clinical study

    Note: Detailed Inclusion-Exclusion will be discussed by the Study Doctor

  • e) CTRI URL link with the above information. http://ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=22415&EncHid=&modid=&compid=%27,%2722415det%27

Indication : Hepatocellular Carcinoma

Dr. Sewanti Limaye Centre for Cancer III International Ongoing

Clinical Trial Title : A prospective, observational study to evaluate effectiveness and safety of fixed dose combination of Indacaterol maleate 110 mcg + Glycopyrronium bromide 50 mcg in stable Chronic Obstructive Pulmonary Disease (COPD) patients. (Protocol No.: CQVA149AIN01)

Indication : Chronic Obstructive Pulmonary Disease

Dr. S.P Rai Pulmonary Medicine IV National Completed

Clinical Trial Title : An Open-label, Single-Arm, Multicentre, Phase IV Trial to Evaluate the Safety of Firmagon® in Androgen Deprivation Therapy in Indian Patients Diagnosed with Advanced Hormone-dependent Prostate Cancer. (Protocol No.: 000201)

Indication : Prostate Cancer

Dr. Yuvaraja T.B Centre for Cancer Registry National Completed

Clinical Trial Title : Advanced BRADYCARdia Device Feature Utilization and Clinical OutcomEs II (BRADYCARE II).

Indication : Bradycardia

Dr. Jamshed Dalal Centre for Cardiac Sciences Registry National Completed

Clinical Trial Title : A postmarketing surveillance to assess the safety of Gardasil in healthy females of 9 to 45 years in routine clinical care. (Protocol No.: V501 125-00)

Indication : Human Papilloma VirusVaccine

Dr. Suchitra Pandit Centre for Mother & Child IV National Completed

Clinical Trial Title : International Registry to assess Medical Practice with Longitudinal observation for Treatment of Heart Failure (REPORT-HF)

Indication : Heart Failure

Dr. Jamshed Dalal Centre for Cardiac Sciences Registry International Completed

Clinical Trial Title : CIPLA- A Multicenter Registry of Pulmonary Arterial Hypertension in india

Indication : Pulmonary Arterial Hypertension

Dr. Prashant Bhobhate Children's Heart Centre Registry National Completed

Clinical Trial Title : A multi-center, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of RyzodegTM (insulin degludec/insulin aspart) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India. (Protocol No.: NN5401-4149)

Indication : Diabetes Mellitus

Dr. Dheeraj Kapoor Centre for Diabetes & Bariatric Surgery Registry National Completed

Clinical Trial Title : A multi-center, prospective, open-label, single-arm, non-interventional, post marketing surveillance (PMS) study of Tresiba® (insulin degludec) to evaluate long term safety and efficacy in patients with diabetes mellitus in routine clinical practice in India. (Protocol No.: NN1250-4129)

Indication : Diabetes Mellitus

Dr. Girish Parmar Centre for Diabetes & Bariatric Surgery Registry National Completed

Clinical Trial Title : Evaluation of the Safety and Effectiveness of BOTOX (Botulinum Toxin Type A) in the Treatment of Patients with Urinary Incontinence due to Neurogenic Detrusor Overactivity or Overactive Bladder. A Phase IV Non-interventional Post-marketing Surveillance Study in India. (Protocol No.: Allergen 191622-140)

Indication : Urinary Incontinence

Dr. Sanjay Pandey Urology IV National Completed

Clinical Trial Title : A non-interventional prospective observational Study to understand the usage pattern of Ticagrelor in Indian patients with acute coronary syndrome (TREASURE).

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences Registry National Completed

Clinical Trial Title : Reditux registry to Compare Effectiveness, safety, and resource utilization of Reditux vs. the reference medicinal product to treat Diffuse Large B-Cell Lymphoma (DLBCL) and Chronic Lymphocytic Leukaemia (CCL) in routine clinical practice. (Protocol No.: RI-02-003)

Indication : Diffuse Large B-Cell Lymphoma (DLBCL) and Chronic Lymphocytic Leukaemia (CCL)

Dr. Sameer A. Tulpule Clinical Haematology Registry National Completed

Clinical Trial Title : A phase IV, multicenter, open-label, single-arm study of pertuzumab (in combination with trastuzumab and docetaxel) in first line treatment of Indian patients with HER2-Positive advanced (metastatic or locally recurrent) breast cancer. (Protocol No. ML29282)

Indication : Breast Cancer

Dr. Mandar Nadkarni Centre for Cancer IV National Completed

Clinical Trial Title : A Randomized, open label, parallel group,active controlled Clinical Trialcokinetic-Clinical Trialcodynamic Study with Single dose of Lupin’s Rituximab and Roche’s Rituximab In patients with Rheumatoid Arthritis. (Protocol No.: LRP/RTX/2013/002)

Indication : Rheumatoid Arthritis

Dr. Sunil Kumar Singh Centre for Bone & Joint II International Completed

Clinical Trial Title : A phase 3, Multicenter study to Evaluate the long- term Safety and Efficacy of Baricitinib in Patients with Rheumatoid arthritis. (Protocol No.: I4V-MC-JADY)

Indication : Rheumatoid Arthritis

Dr. Jyotsna Oak Internal Medicine III International Completed

Clinical Trial Title : A Double-blind, Randomized, Parallel Group Study Comparing the Clinical Trialcokinetics, Clinical Trialcodynamics, Safety, Efficacy, and Immunogenicity of Three Anti-CD20 Monoclonal Antibodies in Patients with Moderate to Severe Active, Seropositive Rheumatoid Arthritis with an Inadequate Response to Methotrexate Based Therapy. (Protocol No.: RI-01-003)

Indication : Rheumatoid Arthritis

Dr. Sunil Kumar Singh Centre for Bone & Joint III International Completed

Clinical Trial Title : Epidemiological study to evaluate the prevalence of epidermal growth factor receptor ( EGFR ) mutation status in non-small cell lung cancer (NSCLC) in India

Indication : Non Small Cell Lung Cancer

Dr. Rajesh Mistry Centre for Cancer Observational National Completed

Clinical Trial Title : An open label, prospective, post marketing study to evaluate the safety, tolerability and efficacy of rituximab with glucocorticoids in adult patients with Wegener’s granulomatosis or microscopic polyangiitis. (Protocol No. ML-28550)

Indication : Wegener’s Granulomatosis

Dr. Jyotsna Oak Internal Medicine IV National Completed

Clinical Trial Title : A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have had Limited or No Treatment with Disease-Modifying Antirheumatic DrugsJADZ. (Protocol No.: I4V-MC-JADZ)

Indication : Rheumatoid Arthritis

Dr. Jyotsna Oak Internal Medicine III International Completed

Clinical Trial Title : A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis JADX. (Protocol No.: I4V-MC-JADX)

Indication : Rheumatoid Arthritis

Dr. Jyotsna Oak Internal Medicine III International Completed

Clinical Trial Title : “Medication Use Patterns, Treatment Satisfaction, and Inadequate Control of Osteoporosis Study (MUSIC-OS): an Asia Pacific study of postmenopausal women treated for osteoporosis in clinical practice. (Protocol No.: MK0822-074-00)

Indication : Osteoporosis

Dr. Jyotsna Oak Internal Medicine IV National Completed

Clinical Trial Title : A Phase 3, Randomized, Double-Blind, Active Comparator Study of the Efficacy and Safety of R-TPR-015 (1422015) in Subjects with Active Rheumatoid Arthritis on a stable dose of Methotrexate.

Indication : Rheumatoid Arthritis

Dr. Sunil Kumar Singh Centre for Bone & Joint III National Completed

Clinical Trial Title : Contraceptive vaginal ring releasing etonogestrel and ethinylestradiol (NuvaRing): Cycle control, acceptability and tolerability study in Indian women.

Indication : Contraception

Dr. Suchitra Pandit Centre for Mother & Child IV National Completed

Clinical Trial Title : Prospective, randomized, double-blind, placebo-controlled, multicenter study with an open label extension period to investigate the efficacy and safety of NT 201 in the treatment of post-stroke spaticity of the upper limb.

Indication : Stroke

Dr. Mohit Bhatt Centre for Neurosciences III International Completed

Clinical Trial Title : Corrona An International Registry of Longitudinal Outcomes and Associated Cardiovascular Comordities in Patients with Rheumatoid Arthritis.

Indication : Rheumatoid Arthritis

Dr. Sunil Kumar Singh Centre for Bone & Joint IV International Completed

Clinical Trial Title : Long term follow-up of antithrombotic management patterns in Acute coronaty syndrome patients. (Epicor)

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences IV National Completed

Clinical Trial Title : A randomized, double-blind, placebo-controlled study of secukinumab to demonstrate the efficacy at 24 weeks and to assess the safety, tolerability and long term efficacy up to 2 years in patients with active rheumatoid arthritis who have an inadequate response to anti-TNFα agents. (CAIN457F2302)

Indication : Rheumatoid Arthritis

Dr. Jyotsna Oak Centre for Bone & Joint III International Completed

Clinical Trial Title : An Observational, prospective, open label study to assess effectiveness, safety and tolerability of onces-yearly treatment with zoledronic acid in osteoporotic patients in a real-world setting. (Protocol No.: AZURE)

Indication : Osteoporosis

Dr. Sunil Kumar Singh Centre for Bone & Joint IV National Completed

Clinical Trial Title : Phase 3 Study of Pemetrexed, Cisplatin, and Radiotherapy Followed by Consolidation Pemetrexed versus Etoposide, Cisplatin, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer. (Protocol No.: H3E-MC-JMIG).

Indication : Non Small Cell Lung Cancer

Dr. Rajesh Mistry Centre for Cancer III International Completed

Clinical Trial Title : Dyslipidemia: REsidual and Mixed Abnormalities IN spite of Statin therapy; The Dyslipidemia REMAINS Study - A multicenter, prospective, observational study of lipid profiles and treatment patterns at presentation and after 12 weeks of statin therapy among Indian adults presenting with first coronary event. (Protocol No.: MK 0000-204-00)

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences Observational National Completed

Clinical Trial Title : Preladenant – A Phase 3, 40 Week, Active-Controlled, Double-Blind, Double Dummy Extension, Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Protocol No.: P06153)

Indication : Parkinson’s Disease

Dr. Mohit Bhatt Centre for Neurosciences III International Completed

Clinical Trial Title : A Multicentre Retrospective Study to understand anti-thrombotic treatment patterns and outcomes of Acute Coronary Syndrome patients in India”

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences Observational International Completed

Clinical Trial Title : An international, double-blind, parallel-group, placebo-controlled, randomized study: evaluation of the efficacy and safety of phenobarbital as adjunctive therapy in participants (≥ 17 to 70 years old) with partial onset seizures

Indication : Seizures

Dr. Jayanti Mani Centre for Neurosciences III International Completed

Clinical Trial Title : A Prospective, Open-labeled, Multicentric Study to Assess the Safety and Efficacy of Autologous Cultured Chondrocyte (Chondron™) in Subjects with Articular Cartilage Defects of the Knee.

Indication : Articular Cartilage Injury

Dr. Dinshaw Pardiwala Centre for Bone & Joint IV National Completed

Clinical Trial Title : A Phase 3, 12 Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Protocol No. : P04938)

Indication : Parkinson’s Disease

Dr. Mohit Bhatt Centre for Neurosciences III International Completed

Clinical Trial Title : A Phase 3, double-blind, placebo-and active-controlled, dose-range-finding efficacy and safety study of preladenant in subjects with early parkinson’s disease. (Protocol No. P05664)

Indication : Parkinson’s Disease

Dr. Mohit Bhatt Centre for Neurosciences III International Completed

Clinical Trial Title : An international observational longitudinal registry in outpatients with stable coronary artery disease. (CLARIFY)

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences Registry National Completed

Clinical Trial Title : Osteoarthritis synvic-one ( hylan G-F 20 ) Indian post marketing study - OASIS

Indication : Osteoarthritis

Dr. Dinshaw Pardiwala Centre for Bone & Joint III National Completed

Clinical Trial Title : A multicenter, randomized, double-blind, placebo-controlled, 5-arm, parallel-group study to assess rotigotine transdermal system dose response in subjects with advanced-stage Parkinson’s disease (Protocol No. SP921)

Indication : Parkinson’s Disease

Dr. Mohit Bhatt Centre for Neurosciences III International Completed

Clinical Trial Title : A Post marketing study of clinical experience of lipicure (Atorvastatin 80 mg) in patients with acute coronary syndrome (Protocol No. PMS/LIPICURE80/ACS/08)

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences IV National Completed

Clinical Trial Title : A postmarket registry of the biomatrix drug eluting stent, sponsored by biosensors (Protocol no. 09EU03)

Indication : Coronary Artery Disease

Dr. Jamshed Dalal Centre for Cardiac Sciences Registry National Completed
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