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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00355589
First received: July 20, 2006
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  Purpose

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
Hypertension
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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

  Show 60 Study Locations
Sponsors and Collaborators
Pfizer
  More Information

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:
Hypertension
High Blood Pressure
Diuretic
Angiotensin converting enzyme inhibitor
Ambulatory blood pressure monitoring

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

ClinicalTrials.gov processed this record on May 23, 2013