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

NCT00982735 | Completed Results

• 1 other identifier: 502.540
• Study Type: observational
• Target: 987
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Essential hypertensive patients

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2007
• Primary Completion: August 1, 2008
• Last Updated: April 16, 2014
• Results First Posted: March 24, 2010

Record last verified: 2014-03