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

Boehringer Ingelheim

Status: Completed

Conditions: Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT00638911

502.465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33,247 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

2. newly diagnosed patients

3. 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

Trial design

33,247 participants in 1 patient group

Patients with hypertention