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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00638911

Enrollment

33247

Registered

2008-03-19

Start date

2004-09-30

Completion date

Unknown

Last updated

2012-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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

Design outcomes

Primary

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

Secondary

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

Outcome results