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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00904215
Recruitment Status : Completed
First Posted : May 19, 2009
Results First Posted : August 31, 2009
Last Update Posted : April 21, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment
Hypertension Drug: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)

Study Design

Study Type : Observational
Actual Enrollment : 1095 participants
Time Perspective: Prospective
Official 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
Study Start Date : February 2005
Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients from clinics and hospitals in Korea
Criteria

Inclusion Criteria:

  1. Ability to provide written/verbal informed consent in accordance with GCP (Good Clinical Practice) and local legislation
  2. Patients aged 18 ~ under 80
  3. Hypertension as described below:

    • Newly diagnosed patients with hypertension
    • Patients with current antihypertensive therapy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904215


Locations
Korea, Republic of
Boehringer ingelheim Investigational Site 1
Daegu, Korea, Republic of
Boehringer ingelheim Investigational Site 4
Daegu, Korea, Republic of
Boehringer ingelheim Investigational Site 7
Daegu, Korea, Republic of
Boehringer ingelheim Investigational Site 9
Daejeon, Korea, Republic of
Boehringer ingelheim Investigational Site 10
Koyang, Korea, Republic of
Boehringer ingelheim Investigational Site 11
Kwangju, Korea, Republic of
Boehringer ingelheim Investigational Site 3
Kwangju, Korea, Republic of
Boehringer ingelheim Investigational Site 5
Pusan, Korea, Republic of
Boehringer ingelheim Investigational Site 2
Seoul, Korea, Republic of
Boehringer ingelheim Investigational Site 6
Suwon, Korea, Republic of
Boehringer ingelheim Investigational Site 8
Wonju, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00904215     History of Changes
Other Study ID Numbers: 502.487
First Posted: May 19, 2009    Key Record Dates
Results First Posted: August 31, 2009
Last Update Posted: April 21, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Telmisartan
Hydrochlorothiazide
Antihypertensive Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists