NCT00847626|CompletedPhase 3Results

Efficacy and Safety of Azilsartan Medoxomil Combined With Chlorthalidone in Participants With Moderate to Severe Hypertension

A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK 491 Plus Chlorthalidone Fixed-Dose Combination in Participants With Moderate to Severe Hypertension

Takeda ClinicalTrials.gov

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3 other identifiers

TAK-491CLD_3022008-004218-28U1111-1113-8735

Study Type

interventional

Target

1,711

Locations

5 countries

Sites

Timeline

RegisteredFeb 2009

StartedJan 2009

CompletionJul 2010

Brief Summary

The purpose of this study is to determine the efficacy and safety of azilsartan medoxomil combined with chlorthalidone, once daily (QD), in participants with moderate to severe hypertension.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,711

participants targeted

Target at P75+ for phase_3 hypertension

Timeline

Completed

Started Jan 2009

Geographic Reach

5 countries

99 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.5 years study duration

Study Start

First participant enrolled

January 1, 2009

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed

1.6 years until next milestone

Results Posted

Study results publicly available

February 7, 2012

Completed

Last Updated

February 7, 2012

Status Verified

January 1, 2012

Enrollment Period

1.3 years

First QC Date

February 18, 2009

Results QC Date

January 4, 2012

Last Update Submit

January 4, 2012

Conditions

Hypertension

Keywords

HypertensiveBlood Pressure, HighVascular DiseaseCardiovascular DiseaseDrug Therapy

Outcome Measures

Primary Outcomes (2)

Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pooled Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.
Change From Baseline to Week 8 in Trough, Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring (Pairwise Analysis)
The change in trough systolic blood pressure measured at final visit or week 8 relative to baseline. Ambulatory blood pressure monitoring measures blood pressure at regular intervals throughout the day and night. The trough is the average of all measurements recorded from 22 to 24 hours after dosing.
Baseline and Week 8.

Secondary Outcomes (16)

Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
Baseline and Week 8
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pooled Analysis)
Baseline and Week 8.
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring in Black Participants (Pairwise Analysis)
Baseline and Week 8.
Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
Baseline and Week 8.
Change From Baseline to Week 8 in the Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing), as Measured by Ambulatory Blood Pressure Monitoring.
Baseline and Week 8.
+11 more secondary outcomes