NCT01078584

Canadian Study of Trandolapril on Blood Pressure in Hypertensive Patients

A Prospective, Non-interventional, Observational Study To Describe the Effectiveness of Trandolapril (Mavik®) in the Management of Patients Requiring Angiotensin Converting Enzyme Inhibitor Treatment (In-MAU-tion)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,993 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The in-MAU-tion study is conducted to determine the percentage of hypertensive participants with or without diabetes reaching CHEP (Canadian Hypertension Education Program) defined blood pressure targets. Additionally, the study assesses change in renal function (microalbuminuria, estimated glomerular filtration rate) in hypertensive participants treated with trandolapril (Mavik®) and examines patient satisfaction with trandolapril (Mavik®) therapy.

Detailed description

There are no interventional implications in this study. The study runs under consideration of Canadian Hypertension Education Program guidelines and as per standard practice of care. Data collection is recorded on the appropriate case report forms. The data collected consist of: patient demographics (gender, race, age, weight), blood pressure readings, heart rate, coexisting comorbidities, concomitant chronic medications (generic name and dosage), indication and dose for trandolapril (Mavik®) and patient compliance. Laboratory values (microalbuminuria, estimated glomerular filtration rate) are only collected if the data are available for each patient. For baseline values (study Day 0), any laboratory value recorded within the past year prior to the baseline visit (Visit 1) is recorded, if the value is available. As per Canadian Hypertension Education Program recommendations and as a support and educational measure, patients are provided with (1) educational tools (nutrition guidebooks) and (2) home blood pressure monitoring devices. As per research and development guidelines, blood pressure devices were retrieved at the end of the study. Approximately 8,000 hypertensive participants were enrolled in the study at up to 700 sites across Canada. Sample size estimations were based on the assumption that 67.2% of non-diabetic hypertensive participants (assumed to make up to 69% of the eligible participant population) would reach a blood pressure target of \<140/90mm Hg, while 22% of diabetes participants (31% of the eligible population) would meet a blood pressure target of \<130/80 mm Hg with trandolapril (Mavik®) therapy.

Conditions

• Hypertension

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-03-02
• Last updated: 2012-10-25
• Results posted: 2012-10-11

Locations

568 sites across 1 country: Canada