Official Title: “A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Efficacy and Safety of a Combination of Ramipril Plus Hydrochlorothiazide Versus the Component Monotherapies in Subjects With Essential Hypertension”

The purpose of this study is to determine if there is greater blood pressure reduction using ramipril or hydrochlorothiazide alone or ramipril and hydrochlorothiazide together.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Ramipril and hydrochlorothiazide

Primary Measures

• Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.

Secondary Measures

• Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
• Compare the effect on sitting diastolic blood pressure of a dose of an antihypertensive drug taken once daily against half of the same dose taken twice daily.
• Compare the effect on the sitting and standing blood pressure among all treatment groups.
• Compare the safety of each medication regimen stated above.
• Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.

Inclusion Criteria:

• Previously diagnosed, or newly diagnosed essential hypertension. Blood pressure must be within a minimum and maximum range prior to drug treatment.

Exclusion Criteria:

• Inability to discontinue all prior antihypertensive medications
• Heart failure
• History of stroke, myocardial infarction, or chest pain within 3 years, or an abnormal heart rhythm
• Liver or kidney disease
• Certain drugs used to treat other conditions like an enlarged prostate gland, or arthritis
• Allergy or reactions to certain medications used to treat high blood pressure
• Other protocol-defined inclusion and exclusion criteria apply.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: King Pharmaceuticals Research and Development

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00355589

Study ID Number: K749-06-3001

ClinicalTrials.gov Identifier: NCT00355589

Health Authority: United States: Food and Drug Administration