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

Completed

• Conditions: Hypertension

• Registration Number: NCT00982735
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2008-08
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Results First Submitted: 2010-02-09
• Results First Submitted QC: 2010-03-11
• Results First Posted: 2010-03-24
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-26
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 987

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	24 weeks

Secondary Outcome Measures

Name	Time	Method
Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion	24 weeks	A 5-point scale was used by the attending physicians to assess the effectiveness of Telmisartan according to their opinion. The scale was rated from 0 (not satisfactory), 1 (marginal), 2 (satisfactory), 3 (very satisfactory) to 4 (outstanding).
Change From Baseline in Microalbuminuria at 24 Weeks	Baseline and 24 weeks