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Completed

NCT Number: NCT00355589

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

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.

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Key information

Conditions

Hypertension Blood Pressure, High Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cahaba Research Inc., Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ramipril and hydrochlorothiazide

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 24, 2006
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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