| CTRI Number |
CTRI/2010/091/000114 [Registered on: 04/03/2010] |
| Last Modified On: |
14/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the effects of Fixed Dose Combination of 2 drugs, Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) in patients with high blood pressure |
|
Scientific Title of Study
|
Efficacy and Tolerability of Fixed Dose Combination of Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) in patients suffering from stage II/III hypertension |
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| SER/01/2009 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Address |
Not Applicable
N/A
India |
| Phone |
|
| Fax |
|
| Email |
|
|
Details Contact Person
Scientific Query
|
| Name |
Dr. Manjusha Rajarshi |
| Address |
Serdia Pharmaceuticals (India) Pvt. Ltd.,
serdia house
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224162727 |
| Fax |
02224163171 |
| Email |
manjusha.rajarshi@in.netgrs.com |
|
Details Contact Person
Public Query
|
| Name |
Dr. Manjusha Rajarshi |
| Address |
Serdia Pharmaceuticals (India) Pvt. Ltd.,
serdia house
Mumbai
MAHARASHTRA
400012
India |
| Phone |
02224162727 |
| Fax |
02224163171 |
| Email |
manjusha.rajarshi@in.netgrs.com |
|
|
Source of Monetary or Material Support
|
| Serdia Pharmaceuticals (India) Pvt. Ltd. |
| Serdia Pharmaceuticals (India) Pvt. Ltd. |
|
Primary Sponsor
Modification(s)
|
| Name |
Serdia Pharmaceuticals India Pvt Ltd |
| Address |
Serdia House, off Dr SS Rao Road , Parel , Mumbai -400012 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. K. K. Tripathi |
Banaras Hindu University |
Department of Medicine,,-221 005
Varanasi
|
9839044027
kamlakar_tripathi@yahoo.co.in |
| Dr. S. Paramesh |
Bangalore Diabetes Centre |
4C-426, 4th Cross, 2nd block, Kalyan Nagar,-560043
Bangalore
|
08025902546
dr_paramesh@hotmail.com |
| Dr. Deepak Namjoshi |
Criti Care Multi Speciality Hospital & Research Center |
Plot No 39, Opp Juhu Supreme Shopping Center, Main Gulmohar Road, J V P D Scheme Andheri W,-400049
Mumbai
|
02226286644
dr.deepak6@rediffmail.com |
| Dr. Harsh Wardhan |
Dr. Ram Manohar Lohia Hospital |
Department of Cardiology,-110001
New Delhi
|
01123365525
hwardhan@hotmail.com |
| Dr. Uday Jadhav |
MGM New Bombay Hospital |
Plot no. 35, Sector ? 3, Vashi,-400703
Mumbai
|
0222782 2203
umjadhav@vsnl.net |
| Dr. Mohd. Siraj |
Owaisi Hospital & Research Center |
Kanchan bagh, near Santosh nagar,-500058
Hyderabad
|
04024340547
drmdsiraj@rediffmail.com |
| Dr. Jagdish Hiremath |
Poona Hospital and Research Centre |
27, Sadashiv Peth,-411030
Pune
|
02024336444
02024336444
drjagdishhiremath@gmail.com |
| Dr. V. K. Gujral |
Speciality Clinics |
A-158, Defence Colony,-110024
New Delhi
|
01124338572
drgujral19@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee |
Approved |
| Clinical Ethics Forum, Mumbai for Dr. Deepak Namjoshi |
Approved |
| Clinical Ethics Forum, Mumbai For Dr. V. K. Gujral |
Approved |
| Ethics Commitee, RML Hospital, New Delhi |
Approved |
| Ethics Committe Poona Hospital and Research centre for Dr Hiremath |
Approved |
| Ethics Committee, Banaras Hindu University |
Approved |
| Institutional Ethics Committee, Deccan College of Medical Sciences & Allied Hospitals |
Approved |
| M.G.M. New Bombay Hospital Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Stage II/ III hypertension |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indapamide S.R. (1.5 mg) + Amlodipine (5 mg) |
1 tablet daily |
| Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Newly diagnosed untreated hypertensive patients having a baseline blood pressure > 160/100 mmHg) OR
2. Uncontrolled patients of hypertension with a baseline blood pressure > 140/90 mmHg on monotherapy with a Calcium Channel Blocker (CCB)
3. Patients of either sex
4. With confirmed diagnosis of Stage II/ III (moderate to severe) hypertension, as per JNC 7 guidelines
|
|
| ExclusionCriteria |
| Details |
1) Uncontrolled diabetes
2) H/o myocardial infarction within the previous 3 months
3) H/o cerebrovascular event within previous 3 months
4) Uncontrolled arrhythmias
5) H/o Heart failure
6) Patients with severe impaired renal function serum creatinine levels > 5.3 mg/dl and / or serious liver disorders
7) Patients unwilling to give informed consent.
8) Patients with history of hypersensitivity to Indapamide or Amlodipine
9) Any contraindication to Thiazide type diuretic and/or CCB
10) Pregnancy or lactation
11) Patients with any other condition or disease, which in opinion of the investigator could preclude evaluation of response to study medication or hamper the safety of the trial participant.
12) Patients previously enrolled in similar trial in the last 6 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the blood pressure reduction rates in moderate to severe hypertensive patients after treatment with an FDC (Indapamide S.R. 1.5 mg + Amlodipine 5 mg) given once daily in the morning during the study evaluation period |
Day 0, Day 15, Day 30 & Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access the safety and tolerability of Indapamide S.R. 1.5 mg + Amlodipine 5 mg |
Day 0, Day 15, Day 30 & Day 45 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="240"
Sample Size from India="240" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
No Date Specified |
| Date of First Enrollment (Global) |
25/03/2010 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
|
|
Publication Details
|
|
|
Brief Summary
|
Fixed dose combination (FDC) of Indapamide SR + Amlodipine is a new FDC for the Indian market and this proposed study is a part of the marketing approval review process in India. Indapamide SR and Amlodipine are available in the Indian market for past approximately 20 years and are individually marketed for the treatment of hypertension. They are also taken simultaneously to achieve target blood pressure control. For the first time, a pharmaceutically stable formulation is developed by the applicant for the purposes of compliance in the treatment; the efficacy and safety of this formulation in the clinical setting is planned to be evaluated through this phase III registration clinical trial. |
