TROPHY - Candesartan Cilexetil Long-Term Hypertension Prevention Trial

Condition(s) targeted: Hypertension

Intervention: ATACAND (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Atacand Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official 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)

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Efficacy Study

Primary outcome: 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 outcome:

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.

Minimum age: 30 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Research Site, Mobile, Alabama, United States

Research Site, Redondo Beach, California, United States

Research Site, Long Beach, California, United States

Research Site, Tustin, California, United States

Research Site, Santa Ana, California, United States

Research Site, Wilmington, Delaware, United States

Research Site, Washington, District of Columbia, United States

Research Site, Gainsville, Florida, United States

Research Site, Ocala, Florida, United States

Research Site, Bay Pines, Florida, United States

Research Site, Chicago, Illinois, United States

Research Site, Shawnee Mission, Kansas, United States

Research Site, Detroit, Michigan, United States

Research Site, Chelsea, Michigan, United States

Research Site, Minneapolis, Minnesota, United States

Research Site, Jackson, Mississippi, United States

Research Site, St. Louis, Missouri, United States

Research Site, Florissant, Missouri, United States

Research Site, Kansas City, Missouri, United States

Research Site, Williamsville, New York, United States

Research Site, Buffalo, New York, United States

Research Site, Rochester, New York, United States

Research Site, Chapel Hill, North Carolina, United States

Research Site, Asheville, North Carolina, United States

Research Site, Winston-Salem, North Carolina, United States

Research Site, Fargo, North Dakota, United States

Research Site, Canton, Ohio, United States

Research Site, Columbus, Ohio, United States

Research Site, Cleveland, Ohio, United States

Research Site, Oklahoma City, Oklahoma, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, Fleetwood, Pennsylvania, United States

Research Site, Allentown, Pennsylvania, United States

Research Site, Warwick, Rhode Island, United States

Research Site, Providence, Rhode Island, United States

Research Site, Charleston, South Carolina, United States

Research Site, Memphis, Tennessee, United States

Research Site, Dallas, Texas, United States

Research Site, Houston, Texas, United States

Research Site, Richmond, Virginia, United States

Research Site, Morgantown, West Virginia, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: July 1998
Last updated: May 5, 2006