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Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension
This study has been completed.
First Received: April 10, 2008   Last Updated: October 22, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00659607
  Purpose

This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market:

  1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs))
  2. Frequency of incidence and its change in adverse events (AEs)
  3. Factors on the safety profile of the study drug
  4. Factors on the efficacy profile of the study drug

Condition
Hypertension

Study Type: Observational
Study Design: Prospective
Official Title: PMS Study of MicardisPlus Tablet

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 [ Time Frame: Baseline and 2 weeks ]
  • Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 [ Time Frame: Baseline and 2 weeks ]

Enrollment: 6901
Study Start Date: September 2003
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Hospitals and clinics in Korea

Criteria

Inclusion Criteria:

patients diagnosed with essential hypertension

Exclusion Criteria:

patients who took Micardis Plus before participating in this PMS study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659607

  Hide Study Locations
Locations
Korea, Republic of
Boehringer Ingelheim Investigational Site 1
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 2
Busan, Korea, Republic of
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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 502.475
Study First Received: April 10, 2008
Results First Received: July 29, 2009
Last Updated: October 22, 2009
ClinicalTrials.gov Identifier: NCT00659607     History of Changes
Health Authority: Korea, Republic of: Korea Food and Drug Administration

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009



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