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

Condition(s) targeted: Hypertension

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

Phase: Phase 3

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

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

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Blood pressure over 12 weeks

Safety and Tolerability.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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 - Unstable diabetes  (hba1c > 8%), or a change in diabetes medication during study

treatment. patients with stable diabetes may enter the study.

Merck Sharp & Dohme (I.A.) Corp., Taipei 106, Taiwan

Starting date: September 2005
Last updated: February 2, 2007