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

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: irbesartan/amlodipine; Drug: amlodipine

• Registration Number: NCT00956644
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
irbesartan/amlodipine	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
amlodipine	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

Primary Outcome Measures

Name	Time	Method
Mean home systolic blood pressure	At randomisation and week 5

Secondary Outcome Measures

Name	Time	Method
Mean office blood pressure	At randomisation, week 5 and week 10
Mean home diastolic blood pressure	At randomisation, week 5 and week 10

Trial Locations

Locations (40)

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 07601; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 076-004; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 076-002; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 07603; 🇧🇷 São Paulo, Brazil

Sanofi-Aventis Investigational Site Number 15202; 🇨🇱 Santiago, Chile

Sanofi-Aventis Investigational Site Number 15203; 🇨🇱 Santiago, Chile

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