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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00957554
First received: August 11, 2009
Last updated: October 25, 2010
Last verified: October 2010
History of Changes
  Purpose

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

Condition Intervention Phase
Hypertension
 Drug: irbesartan/amlodipine
Drug: irbesartan
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Irbesartan/Amlodipine Fixed Combination Therapy Compared With Irbesartan Monotherapy in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Mean home systolic blood pressure [ Time Frame: At randomisation and week 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean office blood pressure [ Time Frame: At randomisation, week 5 and week 10 ] [ Designated as safety issue: No ]
  • Mean home diastolic blood pressure [ Time Frame: At randomisation, week 5 and week 10 ] [ Designated as safety issue: No ]

Enrollment: 435
Study Start Date: July 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957554

  Show 38 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Nathalie Genes, MD Sanofi
  More Information

No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00957554     History of Changes
Other Study ID Numbers: IRBAM_R_04219
Study First Received: August 11, 2009
Last Updated: October 25, 2010
Health Authority: Mexico: Ethics Committee

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 May 23, 2013