The aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch...
Date First Received: March 6, 2008
Last Updated: October 8, 2008
Verified by: Boehringer Ingelheim Pharmaceuticals, October 2008
Clinical Trial Phase: Phase 4 | Start Date:
Overall Status: Recruiting
Estimated Enrollment: 9435
Brief Summary
Official Title: “PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-Moderate Essential Hypertension”
Condition Keyword(s):
Intervention(s):
The aim of this therapeutic observation is to demonstrate the efficacy and safety of telmisartan or telmisartan and HCTZ in the treatment of patients with mild-to-moderate essential hypertension under normal conditions of use after market launch.
Study Type: Observational
Study Design: N/A
Intervention(s) in this Clinical Trial
- Drug: telmisartan
- Drug: combination of telmisartan and hydrochlorotiazide
Outcome Measures for this Clinical Trial
Primary Measures
- Primary Endpoints will be the change from baseline in mean systolic blood pressure
Secondary Measures
- Secondary Endpoints are clinical control of the BP and response rate. Other secondary Endpoints will be discontinuations and tolerability.
Criteria for Participation in this Clinical Trial
- 1.Male or female patients over the age of 18 years, with mild-to-moderate essential hypertension with values of mean morning seated diastolic BP more than 90 mmHg and less than 109 mmHg and or mean morning seated systolic BP more than 140 mmHg and less than 180 mmHg
- 1. newly diagnosed patients
- 2. patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment
- 1. Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
- 2. Choleastasis and biliary obstructive disorders
- 3. Severe hepatic impairment
- 4. Severe renal impairment creatinine clearance less than 30 ml pro min
- 5. Refractory hypokalaemia hypercalcaemia
- 6. Known hypersensitivity to any component in the formulation of Micardis/Micardis
- Plus
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Boehringer Ingelheim Pharmaceuticals
Overall Clinical Trial Officials and Contacts
Boehringer Ingelheim Study Coordinator Study Chair BI Pharma Ges mbH Wien
Overall Contact: Boehringer Ingelheim Study Coordinator clintriage@rdg.boehringer-ingelheim.com
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00638911
Study ID Number: 502.465
ClinicalTrials.gov Identifier: NCT00638911
Health Authority: Hungary: National Institute of Pharmacy, H-1051 Budapest
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