Official Title: “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 Type: Interventional

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

Intervention(s) in this Clinical Trial

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

Primary Measures

• Blood pressure over 12 weeks
• Safety and Tolerability.

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00400218

Study ID Number: 2006_049

ClinicalTrials.gov Identifier: NCT00400218

Health Authority: Taiwan: National Bureau of Controlled Drugs