Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Amlodipine 5 mg Monotherapy

Hypertension Clinical Trial

— I-COMBINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956644
• Other study ID #: IRBAM_R_04220
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2009
• Last updated: October 25, 2010
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Investigational Site Number 07602	Campinas
Brazil	Sanofi-Aventis Investigational Site Number 076-005	Rio de Janeiro
Brazil	Sanofi-Aventis Investigational Site Number 07605	Rio de Janeiro
Brazil	Sanofi-Aventis Investigational Site Number 07604	São José
Brazil	Sanofi-Aventis Investigational Site Number 076-002	São Paulo
Brazil	Sanofi-Aventis Investigational Site Number 076-004	São Paulo
Brazil	Sanofi-Aventis Investigational Site Number 07601	São Paulo
Brazil	Sanofi-Aventis Investigational Site Number 07603	São Paulo
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	Santiago
Colombia	Sanofi-Aventis Investigational Site Number 17003	Barranquilla
Colombia	Sanofi-Aventis Investigational Site Number 17004	Barranquilla
Colombia	Sanofi-Aventis Investigational Site Number 17002	Medellin
Egypt	Sanofi-Aventis Investigational Site Number 81803	Alexandria
Egypt	Sanofi-Aventis Investigational Site Number 81804	Alexandria
Egypt	Sanofi-Aventis Investigational Site Number 81801	Cairo
Egypt	Sanofi-Aventis Investigational Site Number 81802	Cairo
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	Beirut
Mexico	Sanofi-Aventis Investigational Site Number 48401	Durango
Mexico	Sanofi-Aventis Investigational Site Number 48402	Guadalajara
Mexico	Sanofi-Aventis Investigational Site Number 48403	Guadalajara
Mexico	Sanofi-Aventis Investigational Site Number 48404	Guadalajara
Mexico	Sanofi-Aventis Investigational Site Number 48406	Guadalajara
Mexico	Sanofi-Aventis Investigational Site Number 48405	Mexico
Mexico	Sanofi-Aventis Investigational Site Number 48407	Mexico
Morocco	Sanofi-Aventis Investigational Site Number 50401	Casablanca
Morocco	Sanofi-Aventis Investigational Site Number 50402	Marrakech
Morocco	Sanofi-Aventis Investigational Site Number 50403	Marrakech
Tunisia	Sanofi-Aventis Investigational Site Number 78804	Ariana
Tunisia	Sanofi-Aventis Investigational Site Number 78803	Monastir
Tunisia	Sanofi-Aventis Investigational Site Number 78802	Sfax
Tunisia	Sanofi-Aventis Investigational Site Number 78801	Tunis
Venezuela	Sanofi-Aventis Investigational Site Number 86201	Caracas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Brazil,  Chile,  Colombia,  Egypt,  Lebanon,  Mexico,  Morocco,  Tunisia,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean home systolic blood pressure		At randomisation and week 5	No
Secondary	Mean office blood pressure		At randomisation, week 5 and week 10	No
Secondary	Mean home diastolic blood pressure		At randomisation, week 5 and week 10	No