| CTRI Number |
CTRI/2010/091/001073 [Registered on: 30/09/2010] |
| Last Modified On: |
13/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Safety and Efficacy Of PF-04971729 In Patients With Type 2 Diabetes And Hypertension |
Scientific Title of Study
Modification(s)
|
A 4-Week, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study To Evaluate The Safety, Tolerability And Efficacy Of Once Daily Pf-04971729 And Hydrochlorothiazide In Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic And Blood Pressure Control |
| Trial Acronym |
Not Applicable
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| B1521004 |
Protocol Number |
| NCT01096667 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
: C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Swapnali Raut |
| Designation |
Compliance Oversight Lead |
| Affiliation |
Representing Pfizer Limited |
| Address |
Pfizer Limited, Patel Estate, Off S. V. Road, Jogeshwari West, Mumbai, MAHARASHTRA, 400 102, India
C/O Wyeth Limited, 6th Floor, Platina, Plot No C-59, G Block, Bandra-Kurla Complex, Bandra (E), Mumbai 400098.
Mumbai
MAHARASHTRA
400102
India |
| Phone |
91-9821415224 |
| Fax |
91-22-26525993 |
| Email |
Swapnali.raut@pfizer.com |
|
|
Source of Monetary or Material Support
|
| Pfizer Limited,
Pfizer Centre, Patel Estate,
S. V. Road, Jogeshwari West,
Mumbai 400 102
India
|
|
Primary Sponsor
Modification(s)
|
| Name |
Pfizer Limited |
| Address |
Pfizer Centre, Patel Estate, S. V. Road, Jogeshwari West, Mumbai 400 102, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
|
Countries of Recruitment
|
India
Malaysia
Other
Serbia
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Shriraam Mahadevan |
ACEER |
1st Floor, No 7/12, 15th Cross Street,Shastri Nagar, Adyar-600 020
Chennai
TAMIL NADU |
(0141) 5112042
(0141) 2378914
aceergroup@gmail.com |
| Dr. Mala Dharmalingam |
Bangalore Endocrinology and Diabetes Research Centre |
No. 35, 5th Cross,Maleshwaram Circle-560 003
Bangalore
KARNATAKA |
080-65965758
(080) 41131390
jain.endo@gmail.com |
| Dr. Sanjay Kalra |
Bharti Research Institute of Diabetes and Endocrinology |
Kunjpura,-132 001
Karnal
HARYANA |
(0184) 2268585, 2268484
(0184) 2267885
brideknl@gmail.com |
| Dr Nadeem Rais |
Chowpatty Medical Center |
3, Baig Mansion,,Babulnath Road-400007
Mumbai
MAHARASHTRA |
+91-22-23617112/23620826
:+91-22-23642179
cmctrials@gmail.com |
| Dr. Vaishali Deshmukh |
Deshmukh Clinic |
4th Floor, Mulay Arcade, ,Next to Maharashtra Mandal School, Tilak Road-411 030
Pune
MAHARASHTRA |
020 - 65214388, 25456729;
020 24489215
deshmukhclinic@rediffmail.com |
| Dr. Padmalathadevi Manduva |
Diabetomics India Pvt Ltd |
6-3-349/17B, Hindi Nagar, Behind Panjagutta,Saibaba Temple, Banjara Hills-500 034
Hyderabad
ANDHRA PRADESH |
+91-988541 1110
diabtrials@gmail.com |
| Dr. Vijayam Balaji |
Dr. V. Seshiah Diabetes Research Institute |
Dr Balaji Diabetes Care Center,729 PH Road Aminjikarai-600 029
Chennai
TAMIL NADU |
+91 984 108 1010
balajivijayam@gmail.com |
| Dr. Sanjay Reddy |
Medisys Clinisearch Pvt. Ltd., Bangalore Diabetes Centre |
4C- 426, 4th Block, 2nd Cross, Kalyan Nagar,-560 043
Bangalore
KARNATAKA |
080-25457022, 25456729;
080-25425396, 25424357
drsanjaycreddy@yahoo.com |
| Dr. Jugal Bihari Gupta |
S.R. Kalla Memorial Hospital |
78, Dhuleshwar gardens,,C-Scheme-302001
Jaipur
RAJASTHAN |
(0141) 5112042
(0141) 2378914
guptadrjb@rediffmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Bangalore Endocrinology & Diabetes Research center Ethics Committee on Human Research |
Approved |
| Clinicom Ethics Committee for Evaluation of Protocol for Clinical Research |
Approved |
| Clinicom Ethics Committee for Evaluation of Protocol for Clinical Research for Dr. Padmalathadevi Manduva |
Approved |
| Ethics Committee - Dr V Seshiah Diabetes Research Institute and Dr Balaji Diabetes Care Centre |
Approved |
| Ethics Review Board, Chowpatty Medical Center |
Approved |
| Institutional Ethics Committee for BRIDE |
Approved |
| Medisys Clinisearch Ethical Review Board |
Approved |
| National Ethics Committee |
Approved |
| S. R. Kalla Memorial Ethical Committee for Human Research |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Type 2
Hypertension
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 mg PF-04971729: Experimental: 1 mg PF-04971729 |
Drug: 1 mg PF-04971729
pill (n=1), 1 mg strength + pills (n=2), 0 mg, all once daily x 28-days
|
| Comparator Agent |
12.5mg HCTZ: Active Comparator: 12.5mg hydrochlorothiazide (HCTZ) |
Drug: 12.5mg HCTZ
pill (n=1), 12.5 mg strength + pills (n=2), 0 mg, all once daily x 28-days
|
| Intervention |
25 mg PF-04971729:Experimental:25 mg PF-04971729 |
Drug: 25 mg PF-04971729
pill (n=1), 25 mg strength + pills (n=2), 0 mg, all once daily x 28-days
|
| Intervention |
5 mg PF-04971729: Experimental: 5 mg PF-04971729 |
Drug: 5 mg PF-04971729
pill (n=1), 5 mg strength + pills (n=2), 0 mg, all once daily x 28-days
|
| Intervention |
Placebo: Placebo Comparator: Placebo for PF-04971729 and HCTZ |
Drug: Placebo
Pills (n=3), 0 mg, once daily x 28-days
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
1. Patients with type 2 diabetes and hypertension
2. Medically stable
3. On at least 1 (and up to 2) oral diabetes drugs
4. And up to 2 medicines for blood pressure control
|
|
| ExclusionCriteria |
| Details |
1. Patients with type 1 diabetes
2. Heart attack
3. Stroke
4. Uncontrolled blood pressure
5. Significant kidney disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Placebo-adjusted, change from baseline on average, 24 hour systolic blood pressure (SBP) on Day 28 assessed using 24 hour ambulatory blood pressure monitoring (ABPM) |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Placebo-adjusted, change from baseline on average, daytime, night time and 24-hour diastolic blood pressure (DBP), and pulse rate on Day 28 using 24 hour ABPM |
28 Days |
| Placebo-adjusted, change from baseline on average daytime, night time SBP using 24 hour ABPM |
28 Days |
| Placebo-adjusted, change from baseline in trough SBP, DBP and pulse rate using automated device |
28 Days |
| Placebo-adjusted, change from baseline on 24 hour urinary glucose excretion on Day 28 |
28 Days |
| Placebo adjusted, change from baseline in fasting plasma glucose |
28 Days |
| Placebo-adjusted, change from baseline on average, daytime, night time and 24 hour SBP, DBP, pulse rate on Day 28 using 24 hour ABPM |
28 Days |
| Assessment of clinical safety-related laboratory tests, 12 lead electrocardiograms (ECG), adverse events/serious adverse events including urinary tract and genital fungal infections, hypo- and hyper- glycemia as well as hypo- and hyper tension |
28 Days |
|
Target Sample Size
Modification(s)
|
Total Sample Size="175"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
18/10/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
26/05/2010 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This is a 4 week, phase 2, randomized, double- blind, placebo-controlled, dose-ranging, parallel group study to evaluate the safety, tolerability and efficacy of once daily PF-04971729 and hydrochlorothiazide In patients with type 2 diabetes mellitus with inadequate glycemic and blood pressure control. The primary objective is to evaluate the dose-response of PF-04971729 administered once daily for 4-weeks in adults with T2DM on systolic blood pressure (SBP). The study employed 24hr ambulatory blood pressure monitoring device.
Subject visits completed, site close outs will be completed by end of April 2011
|