REF/2011/03/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Thu, 14 Jul :20:58 GMT) CTRI Number Last Modified On 28/01/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/06/ [Registered on: 02/06/2011] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Placebo Controlled Trial A clinical trial to evaluate whether a potential new drug is an effective and safe way to preserve kidney function and slow down the progression of kidney disease due to Type 2 Diabetes. A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study To Evaluate The Efficacy And Safety Of Once-Daily Administration Of A Phosphodiesterase 5 Inhibitor (PF ) In Adults With Type 2 Diabetes And Overt Nephropathy Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) A NCT Protocol Number ClinicalTrials.gov Details of Principal Investigator,,, C/O Wyeth Pharmaceuticals Private Limited (a subsidiary of Pfizer Inc.), Bandra (E), Details Contact Person (Scientific Query),,, C/O Wyeth Pharmaceuticals Private Limited (a subsidiary of Pfizer Inc.), Bandra (E), Details Contact Person (Public Query) page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study,,, C/O Wyeth Pharmaceuticals Private Limited (a subsidiary of Pfizer Inc.), Bandra (E), Source of Monetary or Material Support > Pfizer Limited, Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West,, Type of Sponsor NIL List of Countries Australia Canada Denmark Hong Kong Malaysia Mexico Poland Republic of Korea Serbia Slovakia South Africa Sweden United Kingdom United States of America of Principal Investigator Dr Somasekhar Mudigonda Dr Vaishali Deshmukh Primary Sponsor Details Pfizer Limited Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West,, Pharmaceutical industry-global NIL of Site Site Phone/Fax/ Clinical Trials Unit Deenanath Mangeshkar Hospital and Research 1st Floor, AIHA Building,Near Apollo Health Street, Apollo Hospitals,Jubilee Hills, Hyderabad Andhra Pradesh , Hyderabad ANDHRA PRADESH Dept of Endocrinology, Erandawane il.com page 2 / 5

3 Details of Ethics Committee Dr Abhay Mutha DrYajnik C S Dr Sudarshan Hebri Ballal Dr Jatin Kothari Centre Diabetes Care & Research Centre Diabetes Unit,KEM Hospital Research Center Manipal Hospital P. D. Hinduja National Hospital and Medical Research Centre , Maharashtra, B-5, Mittal Court, 478 Rasta Peth, , Maharashtra 6th Floor Banoo Coyaji Bldg, Sardar Moodliar Road,,, Maharashtra, Dept of Nephrology 6th Floor, Towards Dental Wing Manipal Hospital, No.98, Rustom Bagh, Old Airport Road, Bangalore Bangalore KARNATAKA Swatantrya Veer Savarkar Marg, Mahim West, Mahim docvaishali@yahoo.co.i n drabhaymutha@gmail.c om csyajnik@hotmail.com s.ballal@manipalhospit als.com jatin_kothari@yahoo.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Diabetes Care Approved 21/01/2011 No Research Centre Ethics Committee Ethics Committee of Manipal Hospitals, Bangalore for Dr. Sudarshan Hebri Ballal Ethics Committee, Applo Hospital for Dr. Somasekhar Mudigonda Institutional Ethics Committee, Deenanath Mangeshkar Hospital and Research Centre Erandawane, for Dr. Vaishali Deshmukh Approved 19/01/2012 No Approved 28/01/2011 No Approved 06/03/2012 No KEM Hospital Research Approved 11/04/2011 No Centre Ethics Committee for Dr.Yajnik C S P. D. Hinduja National Health & Education Society Clinical Research & Ethics Committee for Dr. Jatin Kothari Approved 07/07/2011 No page 3 / 5

4 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Status Date Approved/Obtained 31/05/2011 Health Type Patients Condition Diabetic Nephropathies Type Details Intervention Comparator Agent Age From Age To Gender Details Experimental Intervention: Drug: PF Placebo Comparator Intervention: Drug: Placebo Year(s) Year(s) Both Inclusion Criteria Tablet, 20 mg once daily for 12 Tablet, placebo once daily for Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential. 2. Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an egfr of ml/min/1.73m2. Note: In patients greater than or equal to 18 years and less than or equal to 65 years will be enrolled" 3. Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 1000 mg/g (greater than or equal to 113 mg/mmol) for greater than 3 months. Exclusion Criteria Details Exclusion Criteria 1. Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD. 2. Subjects with poorly controlled diabetes mellitus, defined as HbA1C 9%. 3. Subjects on combination ACE inhibitor/arb therapy Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Centralized Not Applicable Primary Outcome Outcome Timepoints 1. Urine albumin:creatinine ratio (UACR) 12 Secondary Outcome Outcome Timepoints Urine albumin:creatinine ratio at 3, 6 and 16 Urine protein:creatinine ratio at 3, 6, 12 and 16 Estimated glomerular filtration rate at 3, 6, 12 and Systolic, diastolic and mean arterial blood pressure at 3, 6, 12 and Serum creatinine at 3, 6, 12 and Urinary TGFbeta1 at Weeks 3, 6, 12 and 16. Serum highly sensitive C-reactive protein (hs-crp) at Weeks 12 and 16. Serum cystatin C at Weeks 12 and 16 page 4 / 5

5 Powered by TCPDF ( REF/2011/03/ Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary An assessment of the pharmacokinetic parameters of PF Plasma glycosylated hemoglobin (HbA1c). Safety and tolerability measures (AEs, clinical laboratory assessments, physical examination including weight, worsening of edema, increased use of diuretics). Total Sample Size=230 Sample Size from =70 04/08/ /12/2010 Years=0 Months=8 Days=0 Completed Completed Not applicable Additional information under intervention and comparator agent section: Please note that both placebo and PF arm are to be administered on top of standard of care (angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARBs)) page 5 / 5