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

Phase 3

Completed

• Conditions: Hypertension

• Registration Number: NCT00400218
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-01
• Primary Completion: 2006-07-01
• Study Completion: 2006-07-19
• Study First Submitted: 2006-11-15
• Study First Submitted QC: 2006-11-15
• Study First Posted: 2006-11-16
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood pressure over 12 weeks
Safety and Tolerability.