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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00227318

Enrollment

1000

Registered

2005-09-28

Start date

1998-07-31

Completion date

2005-10-31

Last updated

2011-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

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.

Interventions

DRUGATACAND

Study design

Allocation

RANDOMIZED

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

30 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 11, 2026