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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01431508
First received: September 7, 2011
Last updated: October 13, 2011
Last verified: October 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Losartan 50 mg / HCTZ 12.5 mg
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12 [ Time Frame: At Baseline and Week 12 ] [ Designated as safety issue: No ]
    Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.


Enrollment: 15
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431508

Sponsors and Collaborators
Merck
Investigators
Principal Investigator: Du-Yi Lee, M.D. Cheng Ching General Hospital
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01431508     History of Changes
Other Study ID Numbers: MK-0954A-373
Study First Received: September 7, 2011
Results First Received: October 13, 2011
Last Updated: October 13, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Merck:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Hydrochlorothiazide
Losartan
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 19, 2013