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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
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. To evaluate the reduction in BP after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.
  2. To evaluate the incidence of hypertension after 2 years treatment with candesartan cilexetil 16 mg vs placebo in patients with high normal BP.
  3. 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)
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 (NCT number): NCT00227318


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Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Atacand Medical Science Director, MD AstraZeneca
More Information
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Publications of Results:

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 )
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: August 30, 2011
Last Verified: August 2011

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