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

NCT01625494 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2013-01-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Irbesartan/Amlodipine (150/5mg)

Pharmaceutical form: tablet Route of administration: oral

DRUG

Irbesartan/Amlodipine (150/10mg)

Pharmaceutical form: tablet Route of administration: oral

DRUG

Irbesartan/Amlodipine (300/5mg)

Pharmaceutical form: tablet Route of administration: oral

DRUG

Irbesartan/Amlodipine (300/10mg)

Pharmaceutical form:tablet Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Russia

Study Locations

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Entities

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 NCT01625494 on ClinicalTrials.gov