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Irbesartan and Amlodipine Combination in Controlling Blood Pressure

NCT00950066 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2011-01-05

No results posted yet for this study

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.

Conditions

Interventions

DRUG

IRBESARTAN (SR47436)

Oral administration of Irbesartan 150mg or 300mg once a day

DRUG

Amlodipine

Oral administration of Amlodipine 5mg once a day

DRUG

Irbesartan / Amlodipine

Oral administration of Irbesartan 150 mg / Amlodipine 5mg or Irbesartan 300mg / Amlodipine 5mg once a day

DRUG

Placebo

Oral administration of a placebo once a day

Sponsors & Collaborators

Principal Investigators

  • Sanjay Aggarwal, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • India
  • Philippines
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950066 on ClinicalTrials.gov