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

Phase 3
Completed
Conditions
Hypertension
Blood Pressure, High
Registration Number
NCT00355589
Lead Sponsor
Pfizer
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
Not specified
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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.

Trial Locations

Locations (60)

Cahaba Research Inc.

🇺🇸

Birmingham, Alabama, United States

Clinical Research Associates

🇺🇸

Huntsville, Alabama, United States

Pulmonary Associates

🇺🇸

Glendale, Arizona, United States

Impact Clinical Trials

🇺🇸

Beverly Hills, California, United States

Lovelace Scientific Resources, Inc.

🇺🇸

Beverly Hills, California, United States

Associated Pharmaceutical Research Center, Inc.

🇺🇸

Buena Park, California, United States

Marin Endocrine Care and Research

🇺🇸

Greenbrae, California, United States

Memorial Research Medical Clinic

🇺🇸

Long Beach, California, United States

The Intermed Group; Samaritan Medical Tower

🇺🇸

Los Angeles, California, United States

National Research Institute

🇺🇸

Los Angeles, California, United States

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Cahaba Research Inc.
🇺🇸Birmingham, Alabama, United States

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