| CTRI Number |
CTRI/2009/091/000580 [Registered on: 07/08/2009] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Irbesartan & Amlodipine combination in controlling blood pressure.
|
Scientific Title of Study
Modification(s)
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A Prospective, Randomized, Multi-national, Multi-center, Double-Blind, Placebo-Controlled, Six-arm, Parallel-group, Phase II (Factorial Design) Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine (150 mg/ 5 mg and 300 mg/ 5 mg) and Monotherapy (Amlodipine 5 mg, Irbesartan 150 mg and 300 mg) after Eight Weeks of Treatment in Subjects with Uncomplicated Mild to Moderate Essential Hypertension. |
| Trial Acronym |
I-COMBO |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| IRBES_R_04320 |
Protocol Number |
| NCT00950066 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
|
| Designation |
|
| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Deepa Chodankar |
| Designation |
Senior Medical Advisor |
| Affiliation |
Sanofi-Synthelabo (India) Limited |
| Address |
Aventis House
Sir Mathuradas Vasanji Road
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9096867313 |
| Fax |
|
| Email |
deepa.chodankar@sanofi.com |
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Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Deepa Chodankar |
| Designation |
Senior Medical Advisor |
| Affiliation |
Sanofi-Synthelabo (India) Limited |
| Address |
Aventis House
Sir Mathuradas Vasanji Road, Andheri East, Mumbai
Mumbai
MAHARASHTRA
400093
India |
| Phone |
9096867313 |
| Fax |
|
| Email |
deepa.chodankar@sanofi-aventis.com |
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Source of Monetary or Material Support
Modification(s)
|
| sanofi-aventis Singapore Pvt Ltd
6 Raffles Quay,
Singapore |
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Primary Sponsor
Modification(s)
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| Name |
SanofiSynthelabo India Limited |
| Address |
A 101, Sir Mathuradas Vasanji Road Andheri E, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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Countries of Recruitment
Modification(s)
|
India
Philippines
Republic of Korea
Taiwan |
Sites of Study
Modification(s)
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. Brian Pinto |
Holy Family Hospital |
St Andrews Road, Bandra West, ,-400050
Mumbai
MAHARASHTRA |
brianpinto@iifc.info; maheshv@iifc.info; prashant.janbandu@yahoo.co.in |
| Dr. Shireesh Saathe |
Deenanath Mangeshkar Hospital & Research Centre, |
Erandawane ,-411004
Pune
MAHARASHTRA |
shireesh.sathe@gmail.com; prashantmishra@gmail.com |
| Dr.Nilesh Gautam |
Gautams Clinic |
Sujata Building, Flat No. 2, 1st Floor, Juhu Road, Santacruz (W) ,-400054
Mumbai
MAHARASHTRA |
rinigautam@hotmail.com;prachi.pathak@ahirc.com |
| Dr. L. Sreenivasa Murthy |
Life Care Clinic |
,-
Bangalore
KARNATAKA |
lifecareclinic@rediffmail.com; dreams607@yahoo.com; malaybaidya@yahoo.co.in |
| Dr. Jagdish Hiremath |
Poona Hospital & Research Centre, |
,-
Pune
MAHARASHTRA |
dr.vibha_phrc@yahoo.co.in |
| Dr. Atul Abhyankar |
Shree B. D. Mehta Mahavir Heart Institute, |
Athwagate, Ring Road,-
Surat
GUJARAT |
atulda@hotmail.com |
| Dr.Kamaldeep Chawla |
Sterling Hospital |
Opp. INOX, Race Course, Alkapuri,,-390007
Vadodara
GUJARAT |
kychawla@rediffmail.com; dhirens@sterlinghospitals.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Deenanath Mangeshkar Hospital & Research Centre |
Approved |
| Gautams Institutional Ethical Committee |
Approved |
| Heart First Ethics Committee |
Approved |
| Life Care Ethics Committee |
Approved |
| Poona Hospital And Research Centre |
Approved |
| Sterling Hopsital Ethics Committee |
Approved |
| The Bandra Holy Family Medical Research Society |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Hypertension, (1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
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Intervention / Comparator Agent
Modification(s)
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| Type |
Name |
Details |
| Comparator Agent |
Amlodipine 5 mg |
8 weeks |
| Comparator Agent |
Irbesartan 150 mg |
8 weeks |
| Comparator Agent |
Irbesartan300 mg |
8 weeks |
| Comparator Agent |
Placebo |
8 weeks |
| Intervention |
Two Fixed Dose Combinations of Irbesartan / Amlodipine (150 mg/ 5 mg and 300 mg/ 5 mg) |
Two Fixed Dose Combinations of Irbesartan / Amlodipine (150 mg/ 5 mg and 300 mg/ 5 mg) for 8 weeks |
|
Inclusion Criteria
Modification(s)
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| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with uncomplicated mild to moderate essential hypertension (as per European Society of Cardiology Classification of Hypertension)
Treatment naïve subjects (newly diagnosed subjects or subjects currently only on lifestyle modification) with mean SeDBP of 95 to 109 mmHg at both screening and randomization visit (mean of 3 recordings at intervals of 1 minute) Or
Uncontrolled on any anti-hypertensive monotherapy and with mean SeDBP of 90 to 109 mmHg at screening and mean SeDBP of 95 to 109 mmHg at the randomization visit (mean of 3 recordings at intervals of 1 minute).
Signed written informed consent obtained prior to inclusion in the study.
Subjects willing to adhere to protocol and study requirements during the entire study duration.
Subjects having no abnormalities in general physical examination.
|
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| ExclusionCriteria |
| Details |
a.Subjects who are incapable of giving informed consent for the study.
b.Subjects with SeDBP≥110mmHg and / or SeSBP≥180 mmHg measured at Doctor's office during screening or randomization visit
c.Subjects having a difference of > 8 mmHg between any 2 of the 3 SeDBP measurements either at screening or at randomization.
d.Subjects who are on any anti-hypertensive therapy and unable to discontinue the anti-hypertensive therapy safely for a period of at least 2 weeks as required by the protocol.
e.Subjects who cannot be discontinued on medications prohibited by the protocol.
f.Subjects on combination therapies for treatment of hypertension.
g.Subjects with known documented secondary hypertension including (but not limited to) hypertension secondary to coarctation of aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing?s disease, pheochromocytoma, polycystic kidney disease, etc.
h.Subjects with known diabetes (Type 1 or Type 2).
i.Subjects with known documented complications of hypertension including (but not limited to):
1.Cardiovascular disease: Ischemic heart disease (angina, myocardial infarction), heart failure, peripheral vascular disease.
2.Cerebrovascular disease: Stroke, cerebral hemorrhage.
3.Ophthalmic: Retinal hemorrhage, impaired vision, retinal microaneurysms.
4.Subjects with known severe renal impairment (creatinine clearance < 30 ml/min) calculated using the Cockcroft-Gault equation.
k.Subjects with hyperkalemia (>5.1mmol/L) and/or hyponatremia (<133mmol/L).
l.Subjects with known severe hepatic impairment (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt.
m.Subjects with clinically significant abnormalities on ECG
n.Subjects with any other clinical condition which, in the opinion of the Investigator, might interfere with administration of Irbesartan or Amlodipine and evaluation of the study objectives.
o.Subjects with known history of allergy considered due to any of the study drugs or their components, including excipients (lactose) and preservatives.
p.Subjects with known history of substance abuse (drug or alcohol dependency, alcohol, if not stopped, <20gms per day will be allowed during the study period).
q.Subjects known positive for HIV 1 or 2 virus.
r.Subjects with known or suspected impairment of the immune function, and/or receiving immunosuppressive therapy, or having received immunosuppressive therapy within 30 days prior to study entry.
s.Subjects who have received any other investigational drug within 30 days before inclusion.
t.Pregnant (demonstrating a positive serum (β-HCG) pregnancy test at screening visit) or lactating female subjects.
u.Subjects and partners unwilling to employ adequate contraception during the course of the study. Adequate contraception methods include condom, spongy, loop in the uterus, and so on. Contraceptive drugs can not be used.
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Method of Generating Random Sequence
Modification(s)
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Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
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Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Difference in mean change from baseline at the end of 8 weeks in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo |
8 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Difference in mean change from baseline in SeSBP at end of 8 weeks between each FDC, its individual constituents administered as monotherapy and placebo |
8 weeks |
| Difference in mean change from baseline in SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo |
4 weeks |
| The safety and tolerability of the FDCs, monotherapies and placebo will be assessed by the Clinical AEs, including laboratory abnormalities |
During the treatment duration |
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Target Sample Size
Modification(s)
|
Total Sample Size="240"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
04/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
31/07/2009 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Clinical Study Report |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
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This is a prospective randomized, multi-national, multi-center, double-blind, double dummy, placebo-controlled, six-arm, parallel-group, phase II, factorial design study. This study will be conducted in Korea, Taiwan, India and Philippines. The primary endpoint will be the difference in mean change from baseline at the end of 8 weeks in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo. The Secondary endpoint: 1) Difference in mean change from baseline in SeSBP at end of 8 weeks between each FDC, its individual constituents administered as monotherapy and placebo. 2) Difference in mean change from baseline in SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo. 3) Safety endpoints: The safety and tolerability of the FDCs, monotherapies and placebo will be assessed by the Clinical AEs, including laboratory abnormalities. 72 patients will be enrolled from India.
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