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A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone

NCT01456169 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2014-04-23

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of the fixed dose combinations of azilsartan medoxomil plus chlorthalidone (40/12.5 and 40/25 mg), once daily, in participants with grades 2 or 3 essential hypertension who do not reach target blood pressure following treatment with 40 mg azilsartan medoxomil monotherapy after 4 weeks.

Conditions

  • Essential Hypertension

Interventions

DRUG

Azilsartan medoxomil/placebo

Azilsartan medoxomil and placebo to chlorthalidone combination tablets

DRUG

Azilsartan medoxomil - chlorthalidone

Azilsartan medoxomil and chlorthalidone fixed dose combination tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Bulgaria
  • Estonia
  • France
  • Germany
  • Hungary
  • Italy
  • Lithuania
  • Netherlands
  • Poland
  • Serbia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT01456169 on ClinicalTrials.gov