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

Tracking Information

First Received Date ^ICMJE

September 7, 2011

Last Updated Date

October 13, 2011

Start Date ^ICMJE

August 2007

Primary Completion Date

June 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) to Week 12 [ Time Frame: At Baseline and Week 12 ] [ Designated as safety issue: No ]

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

June 2009

Primary Completion Date

June 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.

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01431508

Other Study ID Numbers ^ICMJE

MK-0954A-373

Has Data Monitoring Committee

Responsible Party

Merck

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Du-Yi Lee, M.D.

Cheng Ching General Hospital

Information Provided By

Merck

Verification Date

October 2011

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

To Top