Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of Mild to Moderate Essential Hypertension

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 Overview

• Status: Completed
• Conditions: Hypertension

Detailed Description

Study 502.465(NCT00638911) was planned and conducted as 6 independent substudies with varying country participation. One study database, a data management plan or a TSAP were not planned and do not exist which precludes baseline and outcome analyses.

• Study Type: Observational
• Enrollment (Actual): 33247

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with hypertention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Primary Endpoints will be the change from baseline in mean systolic blood pressure.	4-24 Weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: March 6, 2008
• First Submitted That Met QC Criteria: March 18, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Estimate): May 21, 2012
• Last Update Submitted That Met QC Criteria: May 18, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: 502.465