N/A
N=987
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
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT00982735 ↗Enrolled (actual)
987
Serious AEs
0.0%
Results posted
Mar 2010
Primary outcome: Primary: 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. — 711 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
711 | — |
| SECONDARY Assessment by Attending Physicians on the Effectiveness of Treatment With Telmisartan, According to Their Opinion |
21; 3; 221; 159; 363 | — |
| SECONDARY Change From Baseline in Microalbuminuria at 24 Weeks |
433; 5; 1; 0; 111; 25 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00982735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.