Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

This study has been completed.

First Received on April 10, 2008. Last Updated on 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:

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

Condition
Hypertension

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

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide

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

Show 326 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

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

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Diuretics
Natriuretic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 13, 2012