Study of Efficacy and Safety of Irbesartan/Amlodipine 4 Fixed Combination Therapy in Hypertensive Patients Uncontrolled on Irbesartan or Amlodipine Monotherapy

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Irbesartan/Amlodipine (150/5mg); Drug: Irbesartan/Amlodipine (150/10mg); Drug: Irbesartan/Amlodipine (300/5mg); Drug: Irbesartan/Amlodipine (300/10mg)

• Registration Number: NCT01625494
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To assess the proportion of patients with controlled Office Blood Pressure Measurements (OBPM), defined as Systolic blood pressure \< 140 mmHg and Diastolic blood pressure \<90mmHg, at the end of the study

Secondary Objectives:

* To examine over time the antihypertensive effect of the 4 doses of the fixed combination therapy irbesartan/amlodipine on OBPM (SBP (systolic blood pressure) and DBP (diastolic blood pressure)

* To examine the proportion of patients with controlled OBPM (systolic BP\<140 mm Hg and diastolic BP\<90 mmHg) of the different dose groups over time

* To determine the incidence and severity of adverse events.

Detailed Description

16 weeks

* V1 (week 0): Inclusion visit.

* V2 (Week 4): Irbesartan/amlodipine 150/5 mg fixed combination visit

* V3 (Week 8): 1st dose escalation for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg,

* V4 (Week 12): 2nd Dose escalation visit for patients in whom OBPM is not controlled (SBP ≥ 140 mmHg or DBP ≥ 90mmHg

* V5 (Week 16): End of study visit

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-21
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-17
• Last Update Posted: 2013-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irbesartan/Amlodipine 150/5 mg fixed combination	Irbesartan/Amlodipine (150/5mg)	1 tablet once daily in the morning for 4 weeks Patient will be first treated with irbesartan 150mg or amlodipine 5mg, 1 tablet /day for 4 weeks. If OBPM is controlled on monotherapy at week 4 (SBP \<140 mmHg and DBP\<90 mmHg), patient will be withdrawn from the study
Irbesartan/Amlodipine 150/10 mg fixed combination	Irbesartan/Amlodipine (150/10mg)	1 tablet once daily in the morning for 4 weeks
Irbesartan/Amlodipine 300/5 mg fixed combination	Irbesartan/Amlodipine (300/5mg)	1 tablet once daily in the morning for 4 weeks
Irbesartan/Amlodipine 300/10 mg fixed combination	Irbesartan/Amlodipine (300/10mg)	1 tablet once daily in the morning for 4 weeks. If OBPM is controlled at week 12, patients will continue on the same therapy until the end of the study

Primary Outcome Measures

Name	Time	Method
Proportion of patients with controlled OBPM (SBP<140 mmHg and DBP<90 mmHg) at the end of the study	up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with controlled OBPM by visit and treatment group	up to 16 weeks	at Visit 3 (Week 8), at Visit 4 (Week 12) and at Visit 5 (Week 16)
Mean change in OBPM between 2 visits	up to 16 weeks	Visit 2 (Week 4) and Visit 5 (Week 16), Visit 2 (Week 4) and Visit 4 (week 12), Visit 2 (Week 4) and Visit 5 (Week 16), Visit 3 (Week 8) and Visit 4 (Week 12), Visit 3 (Week 8) and Visit 5 (Week 16)
Number of patients with adverse events	up to 16 weeks
Number of patients who discontinue from the study due to adverse events	up to 16 weeks
Number of patients with abnormal liver function	up to 16 weeks	As measured by AST, ALT, total bilirubin and serum creatinine

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇷🇺 Moscow, Russian Federation