TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial
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)
2 other identifiers
interventional
1,000
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 hypertension
Started Jul 1998
Longer than P75 for phase_3 hypertension
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 1998
CompletedFirst Submitted
Initial submission to the registry
September 26, 2005
CompletedFirst Posted
Study publicly available on registry
September 28, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2005
CompletedAugust 30, 2011
August 1, 2011
7.3 years
September 26, 2005
August 29, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (42)
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
Related Publications (2)
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.
PMID: 16537662RESULTKang 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.
PMID: 25627429DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Atacand Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2005
First Posted
September 28, 2005
Study Start
July 1, 1998
Primary Completion
October 1, 2005
Study Completion
October 1, 2005
Last Updated
August 30, 2011
Record last verified: 2011-08