Trial Information

Summary: HYPERTENSION RESEARCH - A STUDY TO INVESTIGATE A TRIPLE COMBINATION APPROACH

We are looking for people at least 18 years old, who are in general good health, who have been diagnosed with hypertension, or who are concerned that they might have high blood pressure to take part in a clinical research trial at our center in Wheat Ridge, Colorado.

Recent studies have shown that a majority of people with hypertension will require 2 or more antihypertensive medications in order to control their high blood pressure adequately. The purpose of this study is to demonstrate that an investigational study medication composed of a triple combination of antihypertensive medications is more effective in lowering seated blood pressure levels in people with hypertension than dual combinations of the same medications.

• Duration of the study is 52 weeks, plus a 1 to 3 week screening period; there is also a pre-study visit.
• The investigational study drug is a fixed dose combination of three drugs: a well known diuretic, an angiotensin receptor blocker (ARB), and a calcium channel blocker (CCB). The comparator drugs are dual combinations of the three drugs: diuretic with ARB, diuretic with CCB, ARB with CCB. Study subjects will be assigned to one of 12 treatment sequences during the first 12 weeks of the study. The final 40 weeks of the study will be open-label treatment starting with a slightly lower dose of the triple combination investigational medication, with up-titration of dosing for those study volunteers who need it.
• Study procedures include study related physical exams, ECG's, labwork, and blood pressure monitoring.
• Compensation for study related time and/or travel is available to qualified study participants.
• NOTE: There is no compensation for a Pre-Screen Visit.
• There is no charge for participation.
• Investigator: William Elzi, M.D. of Wheat Ridge Internal Medicine

Patient Inclusion Criteria
Partial List

• Male or female, at least 18 years old
• Study volunteers must be diagnosed with hypertension, or be concerned that they may have high blood pressure
• Females of childbearing potential must be willing to practice birth control throughout the study (by using oral or patch contraceptive, injectable or implantable contraceptive, intrauterine device, diaphragm or female condom plus spermicide); and may not be currently pregnant or lactating

Patient Exclusion Criteria
More entry criteria will be assessed at study visits.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.