Irbesartan/Amlodipine in Hypertensive Patients Uncontrolled on Irbesartan 150 mg Monotherapy

Phase 3

Completed

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

• Registration Number: NCT00957554
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To demonstrate that the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg is superior to that of irbesartan 300 mg monotherapy in lowering systolic blood pressure (SBP) as measured by home blood pressure measurement (HBPM) after 10 weeks of treatment (W10)

Secondary Objective:

* To compare the antihypertensive efficacy of the fixed combination irbesartan/amlodipine 300/5 mg with that of irbesartan 300 mg monotherapy after 10 weeks of treatment (W10)

* To compare the antihypertensive efficacy of the fixed combination therapy irbesartan/amlodipine 150/5 mg with that of irbesartan 150 mg monotherapy after 5 weeks of treatment (W5)

* 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: 2009-08-11
• Study First Submitted QC: 2009-08-11
• Study First Posted: 2009-08-12
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-25
• Last Update Posted: 2010-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

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: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan/amlodipine 150/5 mg fixed combination for 5 weeks followed by irbesartan/amlodipine 300/5 mg fixed combination for additional 5 weeks
irbesartan	irbesartan	Before randomisation: irbesartan 150 mg for 7 to 10 days (common in the 2 arms) then After randomisation: irbesartan 150 mg for 5 weeks followed by irbesartan 300 mg for 5 additional weeks

Primary Outcome Measures

Name	Time	Method
Mean home systolic blood pressure	At randomisation and week 10

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 (38)

Sanofi-Aventis Investigational Site Number 07605; 🇧🇷 Belo Horizonte, Brazil

Sanofi-Aventis Investigational Site Number 07602; 🇧🇷 Caxias do Sul, Brazil

Sanofi-Aventis Investigational Site Number 07604; 🇧🇷 Maceió, Brazil

Sanofi-Aventis Investigational Site Number 07601; 🇧🇷 Sorocaba, Brazil

Sanofi-Aventis Investigational Site Number 07603; 🇧🇷 São José do Rio Preto, Brazil

Sanofi-Aventis Investigational Site Number 17001; 🇨🇴 Barranquilla, Colombia

Sanofi-Aventis Investigational Site Number 17002; 🇨🇴 Barranquilla, Colombia

Sanofi-Aventis Investigational Site Number 17003; 🇨🇴 Cartagena, Colombia

Sanofi-Aventis Investigational Site Number 32001; 🇬🇹 Guatemala, Guatemala

Sanofi-Aventis Investigational Site Number 32002; 🇬🇹 Guatemala, Guatemala

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