Irbesartan and Amlodipine Combination in Controlling Blood Pressure (I-COMBO)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00950066
First received: July 30, 2009
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo.

The secondary objectives are:

  • to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.
  • to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.

Condition Intervention Phase
Hypertension
Drug: IRBESARTAN (SR47436)
Drug: Amlodipine
Drug: Irbesartan / Amlodipine
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Study to Evaluate the Safety and Efficacy of Two Fixed Dose Combinations of Irbesartan / Amlodipine and Monotherapy After Eight Weeks of Treatment in Subjects With Uncomplicated Mild to Moderate Essential Hypertension

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo [ Time Frame: At week 0, week 2, week 4 and week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo [ Time Frame: At week 0, week 2, week 4 and week 8 ] [ Designated as safety issue: No ]
  • Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo [ Time Frame: At week 0, week 2, week 4 ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: July 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo

Before randomization (common with other arms):

There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.

After randomization:

8 weeks of treatment with placebo once a day.

Drug: Placebo
Oral administration of a placebo once a day
Active Comparator: Irbesartan 150mg

Before randomization (common with other arms):

There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.

After randomization:

8 weeks of treatment with Irbesartan 150 mg once a day.

Drug: IRBESARTAN (SR47436)
Oral administration of Irbesartan 150mg or 300mg once a day
Active Comparator: Irbesartan 150 mg / Amlodipine 5 mg

Before randomization (common with other arms):

There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.

After randomization:

8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day.

Drug: Irbesartan / Amlodipine
Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day
Active Comparator: Amlodipine

Before randomization (common with other arms):

There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.

After randomization:

8 weeks of treatment with Amlodipine 5 mg once a day.

Drug: Amlodipine
Oral administration of Amlodipine 5mg once a day
Active Comparator: Irbesartan 300 mg

Active Comparator: Irbesartan

Before randomization (common with other arms):

There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.

After randomization:

8 weeks of treatment with Irbesartan 300 mg once a day.

Drug: IRBESARTAN (SR47436)
Oral administration of Irbesartan 150mg or 300mg once a day
Active Comparator: Irbesartan 300 mg / Amlodipine 5 mg

Before randomization (common with other arms):

There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy.

After randomization:

8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day.

Drug: Irbesartan / Amlodipine
Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • Subjects who are incapable of giving informed consent for the study.
  • Subjects with SeDBP > or = 110mmHg and / or SeSBP > or = 180 mmHg measured at Doctor's office during screening or randomization visit
  • Subjects having a difference of > 8 mmHg between any 2 of the 3 SeDBP measurements either at screening or at randomization.
  • 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.
  • Subjects who cannot be discontinued on medications prohibited by the protocol.
  • Subjects on combination therapies for treatment of hypertension.
  • 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.
  • Subjects with known diabetes (Type 1 or Type 2).
  • Subjects with known documented complications of hypertension including (but not limited to):

    • Cardiovascular disease: Ischemic heart disease (angina, myocardial infarction), heart failure, peripheral vascular disease.
    • Cerebrovascular disease: Stroke, cerebral hemorrhage.
    • Ophthalmic: Retinal hemorrhage, impaired vision, retinal microaneurysms.
  • Subjects with known severe renal impairment (creatinine clearance < 30 ml/min) calculated using the Cockcroft-Gault equation.
  • Subjects with hyperkalemia (>5.1mmol/L) and/or hyponatremia (<133mmol/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.
  • Subjects with clinically significant abnormalities on ECG
  • 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.
  • Subjects with known history of allergy considered due to any of the study drugs or their components, including excipients (lactose) and preservatives.
  • 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).
  • Subjects known positive for HIV 1 or 2 virus.
  • 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.
  • Subjects who have received any other investigational drug within 30 days before inclusion.
  • Pregnant (demonstrating a positive serum (ß-HCG) pregnancy test at screening visit) or lactating female subjects.
  • Subjects and partners unwilling to employ adequate contraception during the course of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950066

Locations
India
Sanofi-Aventis Administrative Office
Mumbai, India
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Sanjay Aggarwal, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00950066     History of Changes
Other Study ID Numbers: IRBES_R_04320
Study First Received: July 30, 2009
Last Updated: January 4, 2011
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Irbesartan
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on July 28, 2014