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OpenTrials
Completed

NCT Number: NCT02242838

Post-Marketing Surveillance of Micardis® (Telmisartan) in Patients With Hypertension

The primary objective of this survey is to prospectively investigate safety and efficacy in patients with hypertension treated with telmisartan in proper use in medical practice over a long period

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with hypertension

Exclusion criteria

Patients with the following conditions

  • Patients with a history of hypersensitivity of this product
  • Women in pregnancy (included the possibility of pregnancy)
  • Patients with severe biliary obstructive disorders or severe hepatic insufficiency

Treatment and study plan

Telmisartan

Drug

Other names: Micardis®

Primary outcomes

  1. Number of patients with adverse drug reactions

    Time frame: up to 1 year

  2. Incidence of adverse drug reactions

    Time frame: up to 1 year

    classified by Medical Dictionary for Regulatory Activities (MedDRA) terminology

  3. Change in Mean systolic blood pressure (SBP)

    Time frame: up to 1 year

  4. Change in Mean diastolic blood pressure (DBP)

    Time frame: up to 1 year

Secondary outcomes

  1. Overall assessment of efficacy by investigator on 4-point scale

    Time frame: at 3 month, after 1 year

  2. Change in pulse rate

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Post-Marketing Surveillance of Micardis® (Telmisartan) Special Drug Use-results Survey on Long-term Treatment

Important dates

Study start
2003
Primary completion
2006
First posted
Sep 17, 2014
Registry last updated
Sep 17, 2014

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.

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