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TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00227318
First Posted: September 28, 2005
Last Update Posted: August 30, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
September 26, 2005
September 28, 2005
August 30, 2011
July 1998
October 2005   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00227318 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Hypertension
Drug: ATACAND
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
October 2005
October 2005   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00227318
SH-AHM-0030
D2455L00010 ( Other Identifier: AstraZeneca )
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Atacand Medical Science Director, MD AstraZeneca
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP