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Clinical Trial for Individuals With Moderate to Severe Hypertension
This study is currently recruiting participants.
Verified by Clinical Innovations, May 2009
First Received: April 30, 2009   Last Updated: May 1, 2009   History of Changes
Sponsored by: Clinical Innovations
Information provided by: Clinical Innovations
ClinicalTrials.gov Identifier: NCT00892645
  Purpose

The investigators are conducting a clinical study for individuals with moderate to severe hypertension.


Condition Intervention Phase
Hypertension
Drug: TAK-491 Plus Chlorthalidone
Drug: Placebo
Phase III

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Chlorthalidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of TAK-491 Plus Chlorthalidone Fixed-Dose Combination in Subjects With Moderate to Severe Hypertension

Further study details as provided by Clinical Innovations:

Primary Outcome Measures:
  • Lower blood pressure [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1815
Study Start Date: November 2008
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator Drug: Placebo
Placebo
TAK-491 Plus Chlorthalidone: Experimental Drug: TAK-491 Plus Chlorthalidone
TAK-491 Plus Chlorthalidone

Detailed Description:

A Phase 3, double-Blind, randomized, factorial, efficacy and safety study of TAK-491 plus Chlorthalidone fixed-dose combination in subjects with moderate to severe hypertension.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are 18 years of age or older,
  • Treated with antihypertensive therapy and have a post-washout mean sitting clinic SBP of ≥ 160 and ≤ 190 mm Hg on Day 1 (day prior to randomization) or are treatment naïve and have a mean clinic SBP of ≥ 160 and ≤ 190 mm Hg at the screening visit and on Day 1.
  • Women must be surgically sterile, postmenopausal, or if of childbearing potential, not pregnant or lactating and do not intend to become pregnant during the course of the study and agree to use adequate contraception during the course of the study.
  • Subjects who are capable of understanding and willing to comply with the protocol requirements, willing to sign the informed consent prior to undergoing any study related procedures, willing to discontinue current antihypertensive medication for a 3 to 4-week washout period, and have clinical laboratory results within the reference range for the testing.

Exclusion Criteria:

  • Subjects who have hypersensitivity to angiotensin II receptor blockers or thiazide-type diuretics.
  • Previously been randomized in a TAK-491 study, a mean clinic diastolic blood pressure (DBP) (sitting, trough) > 119 mm Hg.
  • Work a night (third) shift.
  • Have an upper arm circumference < 24 cm or > 42 cm.
  • Secondary hypertension of any etiology.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892645

Contacts
Contact: David Cohen (866) 478-8391 volunteers@citrials.com

Locations
United States, California
Clinical Innovations l CiTrials Recruiting
Costa Mesa, California, United States, 92626
Contact: David Cohen     866-478-8391     volunteers@citrials.com    
Sponsors and Collaborators
Clinical Innovations
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Innovations ( David Poling )
Study ID Numbers: TAK-491CLD_302
Study First Received: April 30, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00892645     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Chlorthalidone
Diuretics
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hypertension

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Membrane Transport Modulators
Chlorthalidone
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009