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

This study has been completed.

First Received: July 20, 2006 Last Updated: November 12, 2007 History of Changes

Sponsor:	King Pharmaceuticals Research and Development
Information provided by:	King Pharmaceuticals Research and Development
ClinicalTrials.gov Identifier:	NCT00355589

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Blood Pressure Medicines High Blood Pressure

Drug Information available for: Hydrochlorothiazide Ramipril

U.S. FDA Resources

Further study details as provided by King Pharmaceuticals Research and Development:

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.

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

King Pharmaceuticals Research and Development

More Information

No publications provided by King Pharmaceuticals Research and Development

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

White WB, Cleveland JM, Rolleri RL; Ramipril-Hydrochlorothiazide Study Group. Utility of semiautomatic clinic and 24-h ambulatory blood pressure measurements to evaluate combination therapy: the Ramipril-Hydrochlorothiazide Hypertension trial. J Hum Hypertens. 2008 Aug;22(8):559-68. Epub 2008 May 8.

Study ID Numbers:	K749-06-3001
Study First Received:	July 20, 2006
Last Updated:	November 12, 2007
ClinicalTrials.gov Identifier:	NCT00355589 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by King Pharmaceuticals Research and Development:

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Sodium Chloride Symporter Inhibitors
Diuretics
Physiological Effects of Drugs
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Ramipril
Pharmacologic Actions
Protease Inhibitors
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010