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

NCT ID: NCT00400218

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-01
• Study Completion Date: 2006-07-19

Brief Summary

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

Conditions

Hypertension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MK0954A, hydrochlorothiazide (+) losartan potassium / Duration of Treatment: 12 Weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2006_049

Identifier Type: -

Identifier Source: secondary_id

0954A-323

Identifier Type: -

Identifier Source: org_study_id