Clinical trial 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
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 1095
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from clinics and hospitals in Korea

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


Eligibility 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)

Primary outcomes:
measure: Change in SBP (Systolic Blood Pressure)
timeFrame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
measure: Change in DBP (Diastolic Blood Pressure)
timeFrame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
measure: Change in WHO-QOL (WHO-Quality Of Life)
timeFrame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Secondary outcomes:
measure: Change in VAS (Visual Analog Scale)
timeFrame: between baseline (visit 1) and after 12 weeks of treatment (visit 3)
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 1
city: Daegu
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 4
city: Daegu
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 7
city: Daejeon
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 9
city: Koyang
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 10
city: Kwangju
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 11
city: Kwangju
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 3
city: Pusan
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 5
city: Seoul
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 2
city: Suwon
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 6
city: Wonju
country: Korea, Republic of
facility: Boehringer ingelheim Investigational Site 8
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: