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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: March 6, 2008
Last updated: May 18, 2012
Last verified: May 2012
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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PMS Assessing the Safety and Efficacy of Telmisartan in Patients With Mild-to-moderate Essential Hypertension

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 33247
Study Start Date: September 2004
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Patients with hypertention

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00638911

Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim Identifier: NCT00638911     History of Changes
Other Study ID Numbers: 502.465
Study First Received: March 6, 2008
Last Updated: May 18, 2012

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017