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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

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ClinicalTrials.gov Identifier: NCT00982735
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : March 24, 2010
Last Update Posted : April 16, 2014
Sponsor:
Information provided by:
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.

Condition or disease
Hypertension

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Study Type : Observational
Actual Enrollment : 987 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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.
Study Start Date : September 2007
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion [ Time Frame: 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).

  2. Change From Baseline in Microalbuminuria at 24 Weeks [ Time Frame: Baseline and 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Essential hypertensive patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982735


Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00982735    
Other Study ID Numbers: 502.540
First Posted: September 23, 2009    Key Record Dates
Results First Posted: March 24, 2010
Last Update Posted: April 16, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases