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

- 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
- 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.

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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 |
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.

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
United States, Alabama | |
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Mobile, Alabama, United States | |
United States, California | |
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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 | |
United States, Delaware | |
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Wilmington, Delaware, United States | |
United States, District of Columbia | |
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Washington, District of Columbia, United States | |
United States, Florida | |
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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 | |
United States, Illinois | |
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Chicago, Illinois, United States | |
United States, Kansas | |
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Shawnee Mission, Kansas, United States | |
United States, Michigan | |
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Chelsea, Michigan, United States | |
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Detroit, Michigan, United States | |
United States, Minnesota | |
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Minneapolis, Minnesota, United States | |
United States, Mississippi | |
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Jackson, Mississippi, United States | |
United States, Missouri | |
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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 | |
United States, New York | |
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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 | |
United States, North Carolina | |
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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 | |
United States, North Dakota | |
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Fargo, North Dakota, United States | |
United States, Ohio | |
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Canton, Ohio, United States | |
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Cleveland, Ohio, United States | |
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Columbus, Ohio, United States | |
United States, Oklahoma | |
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Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
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Allentown, Pennsylvania, United States | |
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Fleetwood, Pennsylvania, United States | |
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Pittsburgh, Pennsylvania, United States | |
United States, Rhode Island | |
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Providence, Rhode Island, United States | |
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Warwick, Rhode Island, United States | |
United States, South Carolina | |
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Charleston, South Carolina, United States | |
United States, Tennessee | |
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Memphis, Tennessee, United States | |
United States, Texas | |
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Dallas, Texas, United States | |
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Houston, Texas, United States | |
United States, Virginia | |
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Richmond, Virginia, United States | |
United States, West Virginia | |
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Morgantown, West Virginia, United States | |
United States, Wisconsin | |
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Milwaukee, Wisconsin, United States |
Study Director: | Atacand Medical Science Director, MD | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |