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

NCT00956644 | Completed Phase 3

• 1 other identifier: IRBAM_R_04220
• Study Type: interventional
• Target: 406
• Locations: 9 countries
• Sites: 40

Brief 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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean home systolic blood pressure

  At randomisation and week 5

Secondary Outcomes (2)

• Mean office blood pressure

  At randomisation, week 5 and week 10

• Mean home diastolic blood pressure

  At randomisation, week 5 and week 10

Study Arms (2)

irbesartan/amlodipine

EXPERIMENTAL

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

Drug: irbesartan/amlodipine

amlodipine

ACTIVE COMPARATOR

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

Drug: amlodipine

Interventions

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

irbesartan/amlodipine

amlodipine DRUG

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

amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (40)

Sanofi-Aventis Investigational Site Number 07602

Campinas, 13059-900, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-005

Rio de Janeiro, 20551-030, Brazil

Location

Sanofi-Aventis Investigational Site Number 07605

Rio de Janeiro, 20551-030, Brazil

Location

Sanofi-Aventis Investigational Site Number 07604

São José, 88103-460, Brazil

Location

Sanofi-Aventis Investigational Site Number 07601

São Paulo, 04025-011, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-004

São Paulo, 04038-002, Brazil

Location

Sanofi-Aventis Investigational Site Number 076-002

São Paulo, 05403-000, Brazil

Location

Sanofi-Aventis Investigational Site Number 07603

São Paulo, 05403-000, Brazil

Location

Sanofi-Aventis Investigational Site Number 15202

Santiago, Chile

Location

Sanofi-Aventis Investigational Site Number 15203

Santiago, Chile

Location

Sanofi-Aventis Investigational Site Number 15204

Santiago, Chile

Location

Sanofi-Aventis Investigational Site Number 15205

Santiago, Chile

Location

Sanofi-Aventis Investigational Site Number 15206

Santiago, Chile

Location

Sanofi-Aventis Investigational Site Number 17003

Barranquilla, Colombia

Location

Sanofi-Aventis Investigational Site Number 17004

Barranquilla, Colombia

Location

Sanofi-Aventis Investigational Site Number 17002

Medellín, Colombia

Location

Sanofi-Aventis Investigational Site Number 81803

Alexandria, Egypt

Location

Sanofi-Aventis Investigational Site Number 81804

Alexandria, Egypt

Location

Sanofi-Aventis Investigational Site Number 81801

Cairo, Egypt

Location

Sanofi-Aventis Investigational Site Number 81802

Cairo, Egypt

Location

Sanofi-Aventis Investigational Site Number 42202

Beirut, Lebanon

Location

Sanofi-Aventis Investigational Site Number 42203

Beirut, Lebanon

Location

Sanofi-Aventis Investigational Site Number 42204

Beirut, Lebanon

Location

Sanofi-Aventis Investigational Site Number 42205

Beirut, Lebanon

Location

Sanofi-Aventis Investigational Site Number 42206

Beirut, Lebanon

Location

Sanofi-Aventis Investigational Site Number 48401

Durango, 34080, Mexico

Location

Sanofi-Aventis Investigational Site Number 48402

Guadalajara, 44656, Mexico

Location

Sanofi-Aventis Investigational Site Number 48403

Guadalajara, 44656, Mexico

Location

Sanofi-Aventis Investigational Site Number 48406

Guadalajara, 44670, Mexico

Location

Sanofi-Aventis Investigational Site Number 48404

Guadalajara, 44680, Mexico

Location

Sanofi-Aventis Investigational Site Number 48405

México, 06140, Mexico

Location

Sanofi-Aventis Investigational Site Number 48407

México, 07330, Mexico

Location

Sanofi-Aventis Investigational Site Number 50401

Casablanca, Morocco

Location

Sanofi-Aventis Investigational Site Number 50402

Marrakesh, Morocco

Location

Sanofi-Aventis Investigational Site Number 50403

Marrakesh, Morocco

Location

Sanofi-Aventis Investigational Site Number 78804

Aryanah, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78803

Monastir, 5000, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78802

Sfax, Tunisia

Location

Sanofi-Aventis Investigational Site Number 78801

Tunis, Tunisia

Location

Sanofi-Aventis Investigational Site Number 86201

Caracas, Venezuela

Location

Related Publications (1)

• 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.

  PMID: 22853848 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Irbesartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Dihydropyridines; Pyridines

Study Officials

• Nathalie Genes, MD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: July 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: October 26, 2010

Record last verified: 2010-10

Locations

CL (5); EG (4); TU (4); VE (1); MO (3); CO (3); BR (8); ME (7); LE (5)