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TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00227318
First received: September 26, 2005
Last updated: August 29, 2011
Last verified: August 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Hypertension | Drug: ATACAND | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind 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) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | July 1998 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 30 Years to 65 Years (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00227318
Show 42 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00227318
Show 42 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Atacand Medical Science Director, MD | AstraZeneca |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00227318 History of Changes |
| Other Study ID Numbers: |
SH-AHM-0030 D2455L00010 ( Other Identifier: AstraZeneca ) |
| Study First Received: | September 26, 2005 |
| Last Updated: | August 29, 2011 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Candesartan cilexetil Candesartan |
Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 22, 2017