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Completed

NCT Number: NCT00904215

An Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

An observational study to investigate the efficacy, safety, tolerability and the effect on quality of life of Telmisartan (Micardis) and Telmisartan with HCTZ (Micardis Plus) in patients with hypertension

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer ingelheim Investigational Site 1, Daegu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
  • Patients aged 18 ~ under 80
  • Hypertension as described below:
  • Newly diagnosed patients with hypertension
  • Patients with current antihypertensive therapy

Exclusion criteria

  • Female subjects who are breastfeeding, pregnant or who plan to be pregnant during the study
  • Known or suspected secondary hypertension(e.g. pheochromocytoma)
  • Patients who have been treated with telmisartan prior to the acquisition of informed consent (including verbal informed consent)

Treatment and study plan

telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)

Drug

Primary outcomes

  1. Change in SBP (Systolic Blood Pressure)

    Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

    The change of the mean SBP

  2. Change in DBP (Diastolic Blood Pressure)

    Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

    The change of the mean DBP

  3. Change in WHO-QOL (WHO-Quality Of Life)

    Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

    World Health Organization-Quality Of Life (WHO-QOL), change in quality of life was assessed.

    Best value=130.0 (highest quality of life), worst value=0.0 (lowest quality of life)

Secondary outcomes

  1. Change in VAS (Visual Analog Scale)

    Time frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)

    VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Post Marketing Observational Study to Investigate the Efficacy, Safety, Tolerability and the Effect on Quality of Life of Telmisartan (Micardis) and Telmisartan With HCTZ (Micardis Plus) in Patients With Hypertension

Important dates

Study start
2005
Primary completion
2007
First posted
May 19, 2009
Registry last updated
Apr 21, 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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