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Trial record 38 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

Hyzaar Asia HEAALTH (0954A-950)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00354991
Recruitment Status : Completed
First Posted : July 20, 2006
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE July 18, 2006
First Posted Date  ICMJE July 20, 2006
Last Update Posted Date May 9, 2017
Actual Study Start Date  ICMJE June 1, 2006
Actual Primary Completion Date April 1, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
Percentage of patients reaching a blood pressure goal (diastolic <90mm Hg for non-diabetics; <80mm Hg for diabetics) after 8 weeks of treatment [ Time Frame: 8 Weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
Percentage of patients reaching a blood pressure goal (diastolic <90mm Hg for non-diabetics; <80mm Hg for diabetics) after 8 weeks of treatment
Change History Complete list of historical versions of study NCT00354991 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2009)
Safety and tolerability [ Time Frame: 13 Weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2006)
Safety and tolerability
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyzaar Asia HEAALTH (0954A-950)
Official Title  ICMJE An Open Label Study to Assess the Efficacy of Losartan/HCTZ Combination Therapy in Patients With Essential Hypertension Who Were Inadequately Controlled on Current Antihypertensive Monotherapy
Brief Summary The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Drug: losartan potassium (+) hydrochlorothiazide
Patients took losartan 50 mg /HCTZ 12.5 mg orally once daily for 13 weeks. At Weeks 0, 4 and 8 if the blood pressure goal was not reached then the losartan/HCTZ combination will be titrated upwards according to the following scheme: losartan 50/HCTZ 12.5 to losartan 100/HCTZ 12.5 to losartan 100/HCTZ 25.
Study Arms  ICMJE Experimental: 1
Losartan/HCTZ
Intervention: Drug: losartan potassium (+) hydrochlorothiazide
Publications * Kim KS, Fan WH, Kim YD, Zhu W, Ngau YY, Tong P, Kim BS, Santos M, Lin WH, Buranakitjaroen P, Massaad R, Smith RD; Asia HEAALTH Study Investigators. Effectiveness of open-label losartan/hydrochlorothiazide combination therapy in Asian patients with hypertension not controlled with ACE inhibitor or ARB monotherapy. Hypertens Res. 2009 Jun;32(6):520-6. doi: 10.1038/hr.2009.42. Epub 2009 Apr 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2009)
437
Original Enrollment  ICMJE
 (submitted: July 19, 2006)
420
Actual Study Completion Date  ICMJE April 1, 2007
Actual Primary Completion Date April 1, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is male or female and = 18 years of age
  • Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal

Exclusion Criteria:

  • History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate
  • Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
  • Previous history of severe essential hypertension
  • History of stroke or myocardial infarction (heart attack)
  • Evidence of renal or liver disease
  • Uncontrolled diabetes mellitus
  • Any known bleeding disorder
  • Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide)
  • Other antihypertensive medications or medications that may affect blood pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Thailand
 
Administrative Information
NCT Number  ICMJE NCT00354991
Other Study ID Numbers  ICMJE 0954A-950
MK0954A-950
2006_012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP