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

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: July 20, 2006
Last updated: October 8, 2012
Last verified: October 2012
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 Intervention Phase
Blood Pressure, High
Drug: Ramipril and hydrochlorothiazide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome 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 Outcome 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.

Study Start Date: July 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00355589

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No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00355589     History of Changes
Other Study ID Numbers: K749-06-3001  B5051001 
Study First Received: July 20, 2006
Last Updated: October 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
High Blood Pressure
Angiotensin converting enzyme inhibitor
Ambulatory blood pressure monitoring

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Sodium Chloride Symporter Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on February 11, 2016