TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

NCT ID: NCT00227318

Last Updated: 2011-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-07-31

Study Completion Date

2005-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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ATACAND

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Atacand Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Mobile, Alabama, United States

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Long Beach, California, United States

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Redondo Beach, California, United States

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Santa Ana, California, United States

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Tustin, California, United States

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Wilmington, Delaware, United States

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Washington D.C., District of Columbia, United States

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Bay Pines, Florida, United States

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Gainsville, Florida, United States

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Ocala, Florida, United States

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Chicago, Illinois, United States

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Shawnee Mission, Kansas, United States

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Chelsea, Michigan, United States

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Detroit, Michigan, United States

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Minneapolis, Minnesota, United States

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Jackson, Mississippi, United States

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Florissant, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Buffalo, New York, United States

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Rochester, New York, United States

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Williamsville, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Canton, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Fleetwood, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Warwick, Rhode Island, United States

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Charleston, South Carolina, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Morgantown, West Virginia, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16537662 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25627429 (View on PubMed)

Other Identifiers

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D2455L00010

Identifier Type: OTHER

Identifier Source: secondary_id

SH-AHM-0030

Identifier Type: -

Identifier Source: org_study_id

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