An Observational Cohort Study to Evaluate the Safety and Efficacy of Micardis Tablets Taken Once Daily at 40 mg/Day and 80 mg/Day in Hypertensive Patients Under Real Life Conditions in Usual Clinical Practice.

Boehringer Ingelheim0 sites987 target enrollmentSeptember 2007

ConditionsHypertension

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Enrollment: 987
Primary Endpoint: Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The "CONTROL" study is an out patient based prospective observational cohort study. The main aim of the study is to survey the safety and efficacy of Micardis 40 mg/day and 80 mg/day under real life conditions in usual clinical practice in essential hypertensive patients in the Kingdom of Saudi Arabia. The patients participating in the study will be surveyed for 24 weeks.

Registry

clinicaltrials.gov

Start Date

September 2007

End Date

August 2008

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Eligibility Criteria

Inclusion Criteria

•Male or female.
•Aged 20 to 80 years old.
•Adult essential hypertensive either newly diagnosed and untreated, or previously treated and uncontrolled patients; sitting blood pressure: systolic BP \> 140 mmHg but \< 180 mmHg, and/or diastolic BP \> 90 mmHg but \< 110 mmHg).
•Patients who are assessed to benefit from the intake of angiotensin II receptor blocker (ARB) monotherapy or as add-on medication.

Exclusion Criteria

•Patients with contraindications to telmisartan use (as per the Micardis® Tablets package insert).
•Known hypersensitivity to the active ingredient or to any of the excipients of Micardis® Tablets.
•Any other clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications.
•Patients participating in any other protocol

Outcomes

Primary Outcomes

Number of Patients Achieving Blood Pressure (BP) Control, Sitting Diastolic BP Over Systolic BP 90 Over 140 mm Hg and/or Reduction From Baseline in Sitting Systolic BP or Diastolic BP More Than 10 mm Hg.

Time Frame: 24 weeks

Secondary Outcomes

Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion(24 weeks)
Change From Baseline in Microalbuminuria at 24 Weeks(Baseline and 24 weeks)