Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy (I-COMBINE)

October 25, 2010 updated by: Sanofi

Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Amlodipine Monotherapy in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy

Primary Objective:

  • To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg is superior to that of amlodipine 5 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 5 weeks of treatment (W5)

Secondary Objective:

  • To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 150/5 mg with that of amlodipine 5 mg monotherapy after 5 weeks of treatment (W5)
  • To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/10 mg with that of amlodipine 10 mg monotherapy at the end of treatment (W10)
  • To examine in each treatment group the change from week 5 to week 10 in SBP and diastolic blood pressure (DBP) assessed by HBPM and by office blood pressure measurement (OBPM)
  • To determine the incidence and severity of adverse events

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

406

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Campinas, Brazil, 13059-900
        • Sanofi-Aventis Investigational Site Number 07602
      • Rio de Janeiro, Brazil, 20551-030
        • Sanofi-Aventis Investigational Site Number 076-005
      • Rio de Janeiro, Brazil, 20551-030
        • Sanofi-Aventis Investigational Site Number 07605
      • São José, Brazil, 88103-460
        • Sanofi-Aventis Investigational Site Number 07604
      • São Paulo, Brazil, 04025-011
        • Sanofi-Aventis Investigational Site Number 07601
      • São Paulo, Brazil, 04038-002
        • Sanofi-Aventis Investigational Site Number 076-004
      • São Paulo, Brazil, 05403-000
        • Sanofi-Aventis Investigational Site Number 076-002
      • São Paulo, Brazil, 05403-000
        • Sanofi-Aventis Investigational Site Number 07603
  • Chile
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 15202
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 15203
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 15204
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 15205
      • Santiago, Chile
        • Sanofi-Aventis Investigational Site Number 15206
  • Colombia
      • Barranquilla, Colombia
        • Sanofi-Aventis Investigational Site Number 17003
      • Barranquilla, Colombia
        • Sanofi-Aventis Investigational Site Number 17004
      • Medellin, Colombia
        • Sanofi-Aventis Investigational Site Number 17002
  • Egypt
      • Alexandria, Egypt
        • Sanofi-Aventis Investigational Site Number 81803
      • Alexandria, Egypt
        • Sanofi-Aventis Investigational Site Number 81804
      • Cairo, Egypt
        • Sanofi-Aventis Investigational Site Number 81801
      • Cairo, Egypt
        • Sanofi-Aventis Investigational Site Number 81802
  • Lebanon
      • Beirut, Lebanon
        • Sanofi-Aventis Investigational Site Number 42202
      • Beirut, Lebanon
        • Sanofi-Aventis Investigational Site Number 42203
      • Beirut, Lebanon
        • Sanofi-Aventis Investigational Site Number 42204
      • Beirut, Lebanon
        • Sanofi-Aventis Investigational Site Number 42205
      • Beirut, Lebanon
        • Sanofi-Aventis Investigational Site Number 42206
  • Mexico
      • Durango, Mexico, 34080
        • Sanofi-Aventis Investigational Site Number 48401
      • Guadalajara, Mexico, 44656
        • Sanofi-Aventis Investigational Site Number 48402
      • Guadalajara, Mexico, 44656
        • Sanofi-Aventis Investigational Site Number 48403
      • Guadalajara, Mexico, 44670
        • Sanofi-Aventis Investigational Site Number 48406
      • Guadalajara, Mexico, 44680
        • Sanofi-Aventis Investigational Site Number 48404
      • Mexico, Mexico, 06140
        • Sanofi-Aventis Investigational Site Number 48405
      • Mexico, Mexico, 07330
        • Sanofi-Aventis Investigational Site Number 48407
  • Morocco
      • Casablanca, Morocco
        • Sanofi-Aventis Investigational Site Number 50401
      • Marrakech, Morocco
        • Sanofi-Aventis Investigational Site Number 50402
      • Marrakech, Morocco
        • Sanofi-Aventis Investigational Site Number 50403
  • Tunisia
      • Ariana, Tunisia
        • Sanofi-Aventis Investigational Site Number 78804
      • Monastir, Tunisia, 5000
        • Sanofi-Aventis Investigational Site Number 78803
      • Sfax, Tunisia
        • Sanofi-Aventis Investigational Site Number 78802
      • Tunis, Tunisia
        • Sanofi-Aventis Investigational Site Number 78801
  • Venezuela
      • Caracas, Venezuela
        • Sanofi-Aventis Investigational Site Number 86201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Established essential hypertension
  • Treated with amlodipine 5 mg monotherapy for at least 4 weeks
  • With uncontrolled BP defined as mean SBP = or > 145 mmHg assessed by OBPM
  • Signed written inform consent obtained prior to inclusion in the study

Randomisation Criteria:

  • Mean SBP = or > 135 mmHg assessed by HBPM
  • Good compliance with the HBPM protocol defined as at least 12 correct measurements performed over the last 6 days of the first period of measurements
  • Creatinine clearance = or > 30 ml/min, determined by Cockroft formula

Exclusion criteria:

  • Mean SBP = or > 180 mm Hg and/or mean DBP = or > 110 mm Hg measured at doctor's office at Visit 1
  • Known or suspected causes of secondary hypertension
  • Patients with bilateral artery stenosis, renal artery stenosis in a solitary kidney, renal transplant or only one functioning kidney
  • Know contraindications or hypersensitivity to either amlodipine or irbesartan or to the combination or history of angioedema related to the administration of an angiotensin II receptor antagonist or any combination of the drugs used
  • Known type 1 diabetes
  • Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal or history or hepatic encephalopathy, esophageal varices, or portocaval shunt
  • Known severe renal impairment (creatinine clearance < 30 ml/mn)
  • Concomitant use of any other antihypertensive treatment
  • Administration of any other investigational drug within 30 days before inclusion
  • Inability to obtain a valid automatic BP measurement recording
  • Presence of any severe medical or psychological condition that, in the opinion of the investigator, indicate that participation in the study is not in the best interest of the patient
  • Presence of any other conditions (e.g.: geographical, social, etc) that would restrict or limit the patient participation for the duration of the study
  • Pregnant or breast feeding women
  • Women of childbearing potential unable or unwilling to use an acceptable method to avoid pregnancy for the entire study period

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: irbesartan/amlodipine
Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 150/10 mg fixed combination for 5 additional weeks
Drug: irbesartan/amlodipine
Pharmaceutical form: 150/5 mg and 150/10 mg tablets (fixed combination) Route of administration: oral Dose regimen: 1 tablet once daily in the morning
Active Comparator: amlodipine
Before randomisation : amlodipine 5 mg for 7 to 10 days (common to 2 arms) then After randomisation : amlodipine 5 mg for 5 weeks followed by amlodipine 10 mg for 5 additional weeks
Drug: amlodipine
Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean home systolic blood pressure
Time Frame: At randomisation and week 5
At randomisation and week 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean office blood pressure
Time Frame: At randomisation, week 5 and week 10
At randomisation, week 5 and week 10
Mean home diastolic blood pressure
Time Frame: At randomisation, week 5 and week 10
At randomisation, week 5 and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Nathalie Genes, MD, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 10, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

October 26, 2010

Last Update Submitted That Met QC Criteria

October 25, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRBAM_R_04220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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