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Clinical Trials/NCT00355589
NCT00355589
Completed
Phase 3

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

Pfizer60 sites in 1 countryJuly 2006
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ConditionsHypertensionBlood Pressure, High
DrugsRamipril and hydrochlorothiazide

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Hypertension
Sponsor
Pfizer
Locations
60
Primary Endpoint
Compare the effects on sitting diastolic blood pressure of two antihypertensive drugs in combination against each antihypertensive alone after an eight week treatment period.
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2006
End Date
March 2007
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Pfizer
Responsible Party
Sponsor

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

  • 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 Sites (60)

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