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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00904215
First received: May 18, 2009
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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 Intervention
Hypertension
Drug: telmisartan/telmisartan + HCTZ (Hydrochlorothiazide)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in SBP (Systolic Blood Pressure) [ Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3) ] [ Designated as safety issue: No ]
    The change of the mean SBP

  • Change in DBP (Diastolic Blood Pressure) [ Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3) ] [ Designated as safety issue: No ]
    The change of the mean DBP

  • Change in WHO-QOL (WHO-Quality Of Life) [ Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3) ] [ Designated as safety issue: No ]

    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:
  • Change in VAS (Visual Analog Scale) [ Time Frame: between baseline (visit 1) and after 12 weeks of treatment (visit 3) ] [ Designated as safety issue: No ]
    VAS indicates the health status of the patient. Best value=100.0 (best health status), worst value=0.0 (worst health status)


Enrollment: 1095
Study Start Date: February 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00904215

Locations
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 1
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 3
Kwangju, Korea, Republic of
Boehringer ingelheim Investigational Site 11
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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00904215     History of Changes
Other Study ID Numbers: 502.487
Study First Received: May 18, 2009
Results First Received: May 22, 2009
Last Updated: April 3, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014