Hyzaar Asia HEAALTH (0954A-950)

May 5, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

437

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Losartan/HCTZ
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 13 Weeks
13 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 18, 2006

First Submitted That Met QC Criteria

July 19, 2006

First Posted (Estimate)

July 20, 2006

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0954A-950
  • MK0954A-950
  • 2006_012

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on losartan potassium (+) hydrochlorothiazide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe