Irbesartan and Amlodipine Combination in Controlling Blood Pressure

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: IRBESARTAN (SR47436); Drug: Irbesartan / Amlodipine; Drug: Placebo; Drug: Amlodipine

• Registration Number: NCT00950066
• Lead Sponsor: Sanofi

Brief Summary

The primary objective is to compare the extent of reduction of mean Seated Diastolic Blood Pressure (SeDBP) at the end of 8 weeks between each Fixed Dose Combination (FDC), its individual constituents administered as monotherapy and placebo.

The secondary objectives are:

* to compare the reduction of mean Seated Systolic Blood Pressure (SeSBP) at the end of 8 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.

* to compare the reduction of mean SeDBP and SeSBP at 4 weeks from baseline between each FDC, its individual constituents administered as monotherapy and placebo.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-30
• Study First Submitted QC: 2009-07-30
• Study First Posted: 2009-07-31
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-04
• Last Update Posted: 2011-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irbesartan 150mg	IRBESARTAN (SR47436)	Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg once a day.
Irbesartan 150 mg / Amlodipine 5 mg	Irbesartan / Amlodipine	Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 150 mg / Amlodipine 5 mg once a day.
Irbesartan 300 mg	IRBESARTAN (SR47436)	Active Comparator: Irbesartan Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg once a day.
Irbesartan 300 mg / Amlodipine 5 mg	Irbesartan / Amlodipine	Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Irbesartan 300 mg / Amlodipine 5 mg once a day.
Placebo	Placebo	Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with placebo once a day.
Amlodipine	Amlodipine	Before randomization (common with other arms): There is an initial washout (placebo run-in) period of 2 weeks for subjects already on anti-hypertensive monotherapy. After randomization: 8 weeks of treatment with Amlodipine 5 mg once a day.

Primary Outcome Measures

Name	Time	Method
Difference in mean change in SeDBP between each FDC, its individual constituents administered as monotherapy and placebo	At week 0, week 2, week 4 and week 8

Secondary Outcome Measures

Name	Time	Method
Difference in mean change in SeSBP between each FDC, its individual constituents administered as monotherapy and placebo	At week 0, week 2, week 4 and week 8
Difference in mean change in SeDBP and SeSBP between each FDC, its individual constituents administered as monotherapy and placebo	At week 0, week 2, week 4

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇳 Taipei, Taiwan