The University of Florida is sponsoring a clinical trial to investigate the safety and efficacy of two different initial medication strategies for hypertension.  The INternational VErapamil/trandolapril STudy (INVEST) will randomize 27,000 patients with hypertension and coronary disease to either a calcium antagonist or non-calcium antagonist-based medication strategy.  No placebos, PROBE design (Prospective Randomized OBservational Evaluation). Patients will be treated for at least 2 years.

Target Group of Patients:

• 50 years or older
• Elevated blood pressure or controlled blood pressure on medications (no washout)
• documented coronary artery disease (angina or old MI or angiography)
• No beta blockers in previous 2 weeks

Randomization Over the Internet:

• Eligibility checking and randomization take place by entering data over the Internet to a secure web site at the University of Florida
• Not a blinded study, all patients receive active FDA approved medications

Blood Pressure Medications:

• Arrive via mail-order pharmacy to patient's home after data entry completed
• Medications provided free for duration of study

Treatment for at least 2 years:

• All patients will be treated for 2 years after last patient enrolled
• Patients are seen at 6 week intervals for 4 visits and then every 6 months

Data Collection:

• No blood specimens
• 3 simple data forms: compliance assessment, brief exam, electronic prescription
• Completion time ~20 min for enrollment visit, <10 min for follow-up visits

Time and compensation:

• Approximate staff time 20-25 min per randomized patient and 10 min for follow-up visits
• Reimbursement $700/randomized patient, 1/2 paid at randomization and 1/2 paid at study close
• Plus various enrollment bonuses ongoing

Patient Enrollment:

• Through the year 2000
• Each site expected to enroll at least 3 patients per month

Regulatory Requirements:

• Approval by local IRB or the central UF IRB
• Signed contract