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Trial record 28 of 73 for:    HYDROCHLOROTHIAZIDE AND LOSARTAN

A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)

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: NCT01431508
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : November 22, 2011
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE September 7, 2011
First Posted Date  ICMJE September 9, 2011
Results First Submitted Date  ICMJE October 13, 2011
Results First Posted Date  ICMJE November 22, 2011
Last Update Posted Date May 5, 2017
Actual Study Start Date  ICMJE August 1, 2007
Actual Primary Completion Date June 1, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2011)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: At Baseline and Week 12 ]
Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2011)
Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) to Week 12 [ Time Frame: At Baseline and Week 12 ]
Change History Complete list of historical versions of study NCT01431508 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Safety and Efficacy in MK-0954A Combination in Participants With Hypertension (MK-0954A-373 AM3)
Official Title  ICMJE An Open-label, Single Arm, Prospective Study to Evaluate the Safety and Anti-hypertensive Efficacy of Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg Combination in Patients With Mild to Moderate Essential Hypertension
Brief Summary This study is being conducted to evaluate the safety and antihypertensive efficacy of MK-0954A (Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg) in participants with mild to moderate essential hypertension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
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 50 mg / HCTZ 12.5 mg
Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks
Other Name: MK-0954A
Study Arms  ICMJE Experimental: Losartan 50 mg / HCTZ 12.5 mg
Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
Intervention: Drug: Losartan 50 mg / HCTZ 12.5 mg
Publications * Not Provided

*   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: September 8, 2011)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 1, 2009
Actual Primary Completion Date June 1, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Participant will have reached the legal age by the time of entrance into the run-in period.
  • Participant has no active medical problem, other than essential hypertension,

which might of itself or by this treatment significantly affect the Participant's blood pressure.

- Participants diagnosed with mild to moderate essential hypertension or

hypertension accompanying with established cardiovascular (CV) and renal diseases who are receiving antihypertensive regimen (exclude diuretic), yet not attaining to treatment goal*.

* Note: For essential hypertension, the goal is to reduce the blood pressure to less than 140/90. For hypertension with established CV and renal diseases, the BP goal is < 130/80. (According to 2007 European Society of Hypertension (ESH) - European Society of Cardiology (ESC) guideline)

  • Participant is either receiving antihypertensive therapy or no treatment.
  • Participants with stable diabetes mellitus may enter the study.

Exclusion criteria:

  • Pregnant or lactating females.
  • Secondary hypertension of any etiology (such as unilateral or bilateral renal

disease, renal artery stenosis, coarctation of the aorta, pheochromocytoma).

  • History of malignant hypertension.
  • Sitting systolic blood pressure >210 mmHg at Visit 1 (Day 0).
  • Participants with unresolved cerebrovascular accident or transient ischemic attack in the acute stage at visit 1.
  • A clinically confirmed myocardial infarction within the recent 3 months.
  • Angina pectoris.
  • Clinically important cardiac arrhythmia.
  • History of unexplained syncope within the prior 2 years, or a known syncopal

disorder.

- Presence of hemodynamically significant obstructive valvular disease of

cardiomyopathy.

  • Percutaneous coronary angioplasty or coronary artery bypass surgery within the prior 3 months of visit 1.
  • Participant with a single functioning kidney.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 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  
 
Administrative Information
NCT Number  ICMJE NCT01431508
Other Study ID Numbers  ICMJE 0954A-373
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Du-Yi Lee, M.D. Cheng Ching General Hospital
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

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