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

Completed

• Conditions: Hypertension

• Registration Number: NCT00904215
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-02
• Primary Completion: 2007-05
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Results First Submitted: 2009-05-22
• Results First Submitted QC: 2009-07-21
• Results First Posted: 2009-08-31
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-03
• Last Update Posted: 2014-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1095

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in SBP (Systolic Blood Pressure)	between baseline (visit 1) and after 12 weeks of treatment (visit 3)	The change of the mean SBP
Change in DBP (Diastolic Blood Pressure)	between baseline (visit 1) and after 12 weeks of treatment (visit 3)	The change of the mean DBP
Change in WHO-QOL (WHO-Quality Of Life)	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

Name	Time	Method
Change in VAS (Visual Analog Scale)	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)

Trial Locations

Locations (11)

Boehringer ingelheim Investigational Site 4; 🇰🇷 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 6; 🇰🇷 Suwon, Korea, Republic of

Boehringer ingelheim Investigational Site 7; 🇰🇷 Daegu, 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 10; 🇰🇷 Koyang, Korea, Republic of

Boehringer ingelheim Investigational Site 8; 🇰🇷 Wonju, Korea, Republic of

Boehringer ingelheim Investigational Site 2; 🇰🇷 Seoul, Korea, Republic of