TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: ATACAND

Study type: Interventional

Funder types: Industry

Identifiers

NCT00227318

SH-AHM-0030

D2455L00010 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 30 to 65 years old

Volunteers: No 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.