Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy (I-ADD)

October 25, 2010 updated by: Sanofi

Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Primary Objective:

To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 10 weeks of treatment (W10)

Secondary Objective:

  • To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)
  • To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks of treatment (W5)
  • 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 (Actual)

435

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
      • Belo Horizonte, Brazil, 30150-221
        • Sanofi-Aventis Investigational Site Number 07605
      • Caxias do Sul, Brazil, 95070-560
        • Sanofi-Aventis Investigational Site Number 07602
      • Maceió, Brazil, 57051-500
        • Sanofi-Aventis Investigational Site Number 07604
      • Sorocaba, Brazil, 18030-083
        • Sanofi-Aventis Investigational Site Number 07601
      • São José do Rio Preto, Brazil, 15015-210
        • Sanofi-Aventis Investigational Site Number 07603
  • Colombia
      • Barranquilla, Colombia
        • Sanofi-Aventis Investigational Site Number 17001
      • Barranquilla, Colombia
        • Sanofi-Aventis Investigational Site Number 17002
      • Cartagena, Colombia
        • Sanofi-Aventis Investigational Site Number 17003
  • Guatemala
      • Guatemala, Guatemala
        • Sanofi-Aventis Investigational Site Number 32001
      • Guatemala, Guatemala
        • Sanofi-Aventis Investigational Site Number 32002
      • Guatemala, Guatemala
        • Sanofi-Aventis Investigational Site Number 32003
      • Guatemala, Guatemala
        • Sanofi-Aventis Investigational Site Number 32004
      • Guatemala, Guatemala
        • Sanofi-Aventis Investigational Site Number 32005
  • Mexico
      • Guadalajara, Mexico, 44340
        • Sanofi-Aventis Investigational Site Number 48402
      • Mexico, Mexico, 11340
        • Sanofi-Aventis Investigational Site Number 48406
      • Mérida, Mexico, 97070
        • Sanofi-Aventis Investigational Site Number 48401
      • San Luis Potosi, Mexico, 72244
        • Sanofi-Aventis Investigational Site Number 48403
      • San Luis Potosi, Mexico, 78200
        • Sanofi-Aventis Investigational Site Number 48407
      • Torreon, Mexico, 27000
        • Sanofi-Aventis Investigational Site Number 48404
      • Zapopan, Mexico, 44210
        • Sanofi-Aventis Investigational Site Number 48408
  • Morocco
      • Casablanca, Morocco
        • Sanofi-Aventis Investigational Site Number 50401
      • Casablanca, Morocco, 20000
        • Sanofi-Aventis Investigational Site Number 50403
      • Casablanca, Morocco
        • Sanofi-Aventis Investigational Site Number 50402
      • Casablanca, Morocco
        • Sanofi-Aventis Investigational Site Number 50405
      • Rabat, Morocco
        • Sanofi-Aventis Investigational Site Number 50404
      • Rabat, Morocco
        • Sanofi-Aventis Investigational Site Number 50406
  • Tunisia
      • Ariana, Tunisia
        • Sanofi-Aventis Investigational Site Number 78805
      • La marsa, Tunisia
        • Sanofi-Aventis Investigational Site Number 78804
      • Menzel Bourguiba, Tunisia
        • Sanofi-Aventis Investigational Site Number 78802
      • Monastir, Tunisia, 5000
        • Sanofi-Aventis Investigational Site Number 78813
      • Sousse, Tunisia
        • Sanofi-Aventis Investigational Site Number 78815
      • Tunis, Tunisia, 1008
        • Sanofi-Aventis Investigational Site Number 78801
      • Tunis, Tunisia, 1008
        • Sanofi-Aventis Investigational Site Number 78812
      • Tunis, Tunisia
        • Sanofi-Aventis Investigational Site Number 78803
      • Tunis, Tunisia
        • Sanofi-Aventis Investigational Site Number 78807
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Sanofi-Aventis Investigational Site Number 784-001
      • Dubai, United Arab Emirates, 4545
        • Sanofi-Aventis Investigational Site Number 784-02
  • Venezuela
      • Maracaibo, 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 irbesartan 150 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 ny Cockroft formula

Exclusion criteria:

  • Mean SBP = or > 180 mmHg and/or mean DBP = or > 110 mmHg 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 has 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
  • Know type 1 diabetes
  • Know severe hepatic impairment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal or history of hepatic encephalopathy, esophageal varices, or portocaval shunt
  • Know 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 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: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 300/5 mg fixed combination for additional 5 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
Active Comparator: irbesartan
Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan 150 mg for 5 weeks followed by irbesartan 300 mg for 5 additional weeks
Drug: irbesartan
Pharmaceutical form: 150 and 300 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean home systolic blood pressure
Time Frame: At randomisation and week 10
At randomisation and week 10

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)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 11, 2009

First Submitted That Met QC Criteria

August 11, 2009

First Posted (Estimate)

August 12, 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_04219

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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