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TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00227318
First received: September 26, 2005
Last updated: August 29, 2011
Last verified: August 2011

September 26, 2005
August 29, 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
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Prevention
Hypertension
Drug: ATACAND
Not Provided
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. Epub 2006 Mar 14.

*   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.
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00227318
SH-AHM-0030, D2455L00010
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