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Completed

NCT Number: NCT00956644

Irbesartan/Amlodipine 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

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Investigational Site Number 07602, Campinas, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Irbesartan/Amlodipine

Drug

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

Amlodipine

Drug

Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning

Primary outcomes

  1. Mean home systolic blood pressure

    Time frame: At randomisation and week 5

Secondary outcomes

  1. Mean office blood pressure

    Time frame: At randomisation, week 5 and week 10

  2. Mean home diastolic blood pressure

    Time frame: At randomisation, week 5 and week 10

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: I-COMBINE

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 11, 2009
Registry last updated
Oct 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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