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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00956644
First received: August 10, 2009
Last updated: October 25, 2010
Last verified: October 2010

August 10, 2009
October 25, 2010
July 2009
August 2010   (final data collection date for primary outcome measure)
Mean home systolic blood pressure [ Time Frame: At randomisation and week 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00956644 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy
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
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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
  • Drug: amlodipine
    Pharmaceutical form: 5 and 10 mg tablets Route of administration: oral Dose regimen: 1 tablet once daily in the morning
  • 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
    Intervention: Drug: irbesartan/amlodipine
  • 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
    Intervention: Drug: amlodipine
Bobrie G; I-COMBINE Study Investigators. I-COMBINE study: assessment of efficacy and safety profile of irbesartan/amlodipine fixed-dose combination therapy compared with amlodipine monotherapy in hypertensive patients uncontrolled with amlodipine 5 mg monotherapy: a multicenter, phase III, prospective, randomized, open-label with blinded-end point evaluation study. Clin Ther. 2012 Aug;34(8):1705-19. doi: 10.1016/j.clinthera.2012.06.026. Epub 2012 Jul 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
406
August 2010
August 2010   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Chile,   Colombia,   Egypt,   Lebanon,   Mexico,   Morocco,   Tunisia,   Venezuela
 
NCT00956644
IRBAM_R_04220
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Nathalie Genes, MD Sanofi
Sanofi
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP