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Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355589
Recruitment Status : Completed
First Posted : July 24, 2006
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Blood Pressure, High Drug: Ramipril and hydrochlorothiazide Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : July 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Compare the effect on sitting diastolic blood pressure of two antihypertensive drugs in combination taken once daily against one antihypertensive drug taken twice daily.
  2. 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.
  3. Compare the effect on the sitting and standing blood pressure among all treatment groups.
  4. Compare the safety of each medication regimen stated above.
  5. Compare the effect on mean 24-hour diastolic blood pressure (ABPM) of the medication regimens stated above.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00355589

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Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT00355589    
Other Study ID Numbers: K749-06-3001
B5051001 ( Other Identifier: Pfizer )
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Pfizer:
High Blood Pressure
Angiotensin converting enzyme inhibitor
Ambulatory blood pressure monitoring
Additional relevant MeSH terms:
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Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors