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

NCT01431508 | Completed Phase 4 Results

• 1 other identifier: 0954A-373
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

  Participants with SiDBP of 95-115 mmHg at the end of Baseline had SiDBP measured after 12 weeks of treatment.

  At Baseline and Week 12

Study Arms (1)

Losartan 50 mg / HCTZ 12.5 mg

EXPERIMENTAL

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

Interventions

Losartan 50 mg / HCTZ 12.5 mg DRUG

Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks

Also known as: MK-0954A

Losartan 50 mg / HCTZ 12.5 mg

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Hypertension

Interventions

Losartan; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Du-Yi Lee, M.D.

  Cheng Ching General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 9, 2011
• Study Start: August 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 22, 2024
• Results First Posted: November 22, 2011

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share