Official Title: “PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-Moderate Essential Hypertension”

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: Other, Prospective

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: telmisartan
• Drug: telmisartan + hydrochlorothiazide

Primary Measures

• Primary Endpoints will be the change from baseline in mean systolic blood pressure
  • Time Frame: 4-24 Weeks
    

Secondary Measures

• Secondary Endpoints are clinical control of the BP and response rate. Other secondary Endpoints will be discontinuations and tolerability.
  • Time Frame: 4-24 Weeks
    

Inclusion Criteria:

• 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

Exclusion Criteria:

• 1. Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
• 2. Cholestasis 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

Lead Sponsor: Boehringer Ingelheim Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Boehringer Ingelheim Study Chair Boehringer Ingelheim Pharmaceuticals  

Overall Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Information obtained from ClinicalTrials.gov on July 02, 2009

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