Using Telmisartan Alone or Combination of Telmisartan -HCTZ in the Treatment of 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.

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

newly diagnosed patients
patients failing to reach target blood pressure of less than 140 on 90 on their current antihypertensive treatment

Exclusion criteria

Pre-menopausal women who do not use adequate contraception who are pregnant or nursing
Cholestasis and biliary obstructive disorders
Severe hepatic impairment
Severe renal impairment creatinine clearance less than 30 ml pro min
Refractory hypokalaemia hypercalcaemia
Known hypersensitivity to any component in the formulation of Micardis/Micardis Plus

Treatment and study plan

Primary outcomes

Primary Endpoints will be the change from baseline in mean systolic blood pressure.

Time frame: 4-24 Weeks

Secondary outcomes

Secondary Endpoints are clinical control of the BP and response rate.

Time frame: 4-24 Weeks
Other secondary Endpoints will be discontinuations and tolerability.

Time frame: 4-24 Weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension

Important dates

Study start: 2004
Primary completion: 2009
First posted: Mar 19, 2008
Registry last updated: May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed