Official Title: “An Open Label Study to Assess the Efficacy of Losartan/HCTZ Combination Therapy in Patients With Essential Hypertension Who Were Inadequately Controlled on Current Antihypertensive Monotherapy”

The objective of the study is to estimate the percentage of patients who reach blood pressure goal after 8 weeks of treatment with losartan/HCTZ combination.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: MK0954A [hydrochlorothiazide (+) losartan potassium]/Duration of Treatment: 13 Weeks

Primary Measures

• Percentage of patients reaching a blood pressure goal (diastolic <90mm Hg for non-diabetics; <80mm Hg for diabetics) after 8 weeks of treatment

Secondary Measures

• Safety and tolerability

Inclusion Criteria:

• Patient is male or female and ≥ 18 years of age.
• Patients with essential hypertension previously treated with antihypertensive medications for at least 4 weeks but did not reach the blood pressure goal

Exclusion Criteria:

• History of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient/subject to participate.
• Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study
• Previous history of severe essential hypertension
• History of stroke or myocardial infarction (heart attack)
• Evidence of renal or liver disease
• Uncontrolled diabetes mellitus
• Any known bleeding disorder
• Known sensitivity or intolerance to the study medication (losartan or hydrochlorothiazide)
• Other antihypertensive medications or medications that may affect blood pressure

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 November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00354991

Study ID Number: 2006_012

ClinicalTrials.gov Identifier: NCT00354991

Health Authority: Thailand: Food and Drug Administration