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Completed

NCT Number: NCT00227318

TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATACAND

Drug

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
1998
Primary completion
2005
Study completion
2005
First posted
Sep 28, 2005
Registry last updated
Aug 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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