TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

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ClinicalTrials.gov Identifier: NCT00227318

Recruitment Status : Completed

First Posted : September 28, 2005

Last Update Posted : August 30, 2011

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

Study Description

Brief Summary:

The purpose of this study is to determine the effectiveness of candesartan cilexetil in preventing hypertension in people with high normal blood pressure. Patients will be randomized to either Candesartan or placebo for an initial 2-year period followed by a second 2-year period of placebo for all patients.

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: ATACAND	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	1000 participants
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Prevention
Official Title:	A Randomized, Double-blind, Placebo-controlled, Multicenter, Long-term Trial of Preventing Hypertension Using Candesartan Cilexetil 16 mg in Patients With High Normal Blood Pressure (TROPHY)
Study Start Date :	July 1998
Actual Primary Completion Date :	October 2005
Actual Study Completion Date :	October 2005

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Hypertension

Drug Information available for: Candesartan Candesartan cilexetil

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

To determine whether candesartan cilexetil 16 mg compared to placebo reduces the crude incidence of hypertension in a population with high normal BP evaluated after a 4-year study period consisting of 2 years of double-blind treatment followed by 2 years

Secondary Outcome Measures :

To evaluate the reduction in BP after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.
To evaluate the incidence of hypertension after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.
To evaluate Health-related Quality of Life yearly during 2 years treatment with candesartan cilexetil 16mg vs placebo and yearly during a 2-year follow up period in patients with high normal BP.

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects between the ages of 30 and 65 (inclusive) at the time of the informed consent process
have an average clinic BP in the high normal range of < 139/85-89 mmHg or 130-139/< 89 mm Hg (high normal BP range) (mean systolic and/or diastolic pressure based on 3 consecutive measurements) derived from the average of clinic visits 1,2 and 3.

Exclusion Criteria:

Have proteinuria >1 + (by dipstick method)
have a stroke, myocardial infarction (MI), transient ischemic attack (TIA), the presence of any clinically significant evidence of atherosclerosis or hypertensive target organ involvement or any significant medical condition that may compromise participation in this study.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227318

Locations

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United States, Alabama
Research Site
Mobile, Alabama, United States
United States, California
Research Site
Long Beach, California, United States
Research Site
Redondo Beach, California, United States
Research Site
Santa Ana, California, United States
Research Site
Tustin, California, United States
United States, Delaware
Research Site
Wilmington, Delaware, United States
United States, District of Columbia
Research Site
Washington, District of Columbia, United States
United States, Florida
Research Site
Bay Pines, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
Ocala, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Kansas
Research Site
Shawnee Mission, Kansas, United States
United States, Michigan
Research Site
Chelsea, Michigan, United States
Research Site
Detroit, Michigan, United States
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
United States, Mississippi
Research Site
Jackson, Mississippi, United States
United States, Missouri
Research Site
Florissant, Missouri, United States
Research Site
Kansas City, Missouri, United States
Research Site
St. Louis, Missouri, United States
United States, New York
Research Site
Buffalo, New York, United States
Research Site
Rochester, New York, United States
Research Site
Williamsville, New York, United States
United States, North Carolina
Research Site
Asheville, North Carolina, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
United States, North Dakota
Research Site
Fargo, North Dakota, United States
United States, Ohio
Research Site
Canton, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Columbus, Ohio, United States
United States, Oklahoma
Research Site
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Research Site
Allentown, Pennsylvania, United States
Research Site
Fleetwood, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Research Site
Providence, Rhode Island, United States
Research Site
Warwick, Rhode Island, United States
United States, South Carolina
Research Site
Charleston, South Carolina, United States
United States, Tennessee
Research Site
Memphis, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
United States, Virginia
Research Site
Richmond, Virginia, United States
United States, West Virginia
Research Site
Morgantown, West Virginia, United States
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States

Sponsors and Collaborators

AstraZeneca

Investigators

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Study Director:	Atacand Medical Science Director, MD	AstraZeneca

More Information

Publications of Results:

Julius S, Nesbitt SD, Egan BM, Weber MA, Michelson EL, Kaciroti N, Black HR, Grimm RH Jr, Messerli FH, Oparil S, Schork MA; Trial of Preventing Hypertension (TROPHY) Study Investigators. Feasibility of treating prehypertension with an angiotensin-receptor blocker. N Engl J Med. 2006 Apr 20;354(16):1685-97. doi: 10.1056/NEJMoa060838. Epub 2006 Mar 14.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kang S, Little RJ, Kaciroti N. Missing not at random models for masked clinical trials with dropouts. Clin Trials. 2015 Apr;12(2):139-48. doi: 10.1177/1740774514566662. Epub 2015 Jan 27.

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Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00227318
Other Study ID Numbers:	SH-AHM-0030 D2455L00010 ( Other Identifier: AstraZeneca )
First Posted:	September 28, 2005 Key Record Dates
Last Update Posted:	August 30, 2011
Last Verified:	August 2011

Additional relevant MeSH terms:

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Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil	Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action

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