Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323)

Evaluate the Safety and Tolerability of Hyzaar(R) (Losartan 50 Mg/ Hydrochlorothiazide 12.5 Mg) In the Treatment of Hypertension

Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is either receiving high blood pressure monotherapy or no treatment
• Patient will have reached the legal age by the time enter the study
• Patients diagnosed with mild to moderate essential high blood pressure or high blood pressure with other conditions such as diabetes or cardiovascular diseases and are taking high blood pressure medication (exclude diuretic), but did not meet treatment goal

Exclusion Criteria:

• Patient with high levels of uric acid in the blood who has received medications for uric acid in the urine within 3 months prior to enrollment
• Patients who are hypersensitive to any component of the study medication
• Patients who are hypersensitive to other sulfonamide-derived drugs
• Patients with anuria (hyzaar(R) is not recommended for patients with hepatic impairment or severe renal impairment, creatinine clearance </= 30 ml/min)
• Unstable diabetes (hba1c > 8%), or a change in diabetes medication during study treatment. patients with stable diabetes may enter the study.

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood pressure over 12 weeks
Safety and Tolerability.

Collaborators and Investigators

• Sponsor: Organon and Co
• Investigators: Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Click here to access a synopsis of the study results.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2005
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): July 19, 2006

Study Registration Dates

• First Submitted: November 15, 2006
• First Submitted That Met QC Criteria: November 15, 2006
• First Posted (Estimated): November 16, 2006

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 13, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Natriuretic Agents; Membrane Transport Modulators; Diuretics; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Sodium Chloride Symporter Inhibitors; Losartan; Hydrochlorothiazide
• Other Study ID Numbers: 0954A-323; 2006_049

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis