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Long-Term Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Hypertension and Kidney Disease

NCT01309828 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2013-12-13

Study results available
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Summary

The purpose of this study is to evaluate long term safety and tolerability of azilsartan medoxomil and chlorthalidone, once daily (QD), compared with olmesartan medoxomil and hydrochlorothiazide in hypertensive participants with moderate renal impairment.

Conditions

  • Safety

Interventions

DRUG

Azilsartan medoxomil and chlorthalidone

Fixed-dose combination tablets.

DRUG

Olmesartan medoxomil and hydrochlorothiazide

Fixed-dose combination tablets.

Sponsors & Collaborators

Principal Investigators

  • Medical Director, Clinical Science · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Bulgaria
  • Germany
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Slovakia
  • Ukraine

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 NCT01309828 on ClinicalTrials.gov