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Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension

NCT00760214 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 885

Last updated 2012-11-15

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil, once daily (QD), compared to ramipril for treating Essential Hypertension.

Conditions

Interventions

DRUG

Azilsartan medoxomil

Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 40 mg, tablets, orally, once daily for up to 22 weeks.

DRUG

Azilsartan medoxomil

Azilsartan medoxomil 20 mg, tablets, orally, once daily for two weeks; then increased to 80 mg, tablets, orally, once daily for up to 22 weeks.

DRUG

Ramipril

Ramipril 2.5 mg, tablets, orally, once daily for two weeks; then increased to 10 mg, tablets, orally, once daily for up to 22 weeks.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda Global Research & Development Center (Europe), Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Bulgaria
  • Estonia
  • Finland
  • Germany
  • Netherlands
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Sweden

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 NCT00760214 on ClinicalTrials.gov