Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension - Tabular View

Tracking Information

First Received Date ^ICMJE

April 10, 2008

Last Updated Date

October 22, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Change From Baseline in SBP (Systolic Blood Pressure) at weeks2 [ Time Frame: Baseline and 2 weeks ]
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 [ Time Frame: Baseline and 2 weeks ]

Change History

Complete list of historical versions of study NCT00659607 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Telmisartan+HCTZ (Hydrochlorothiazide), Hypertension

Official Title ^ICMJE

PMS Study of MicardisPlus Tablet

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Prospective

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

6901

Completion Date

Primary Completion Date

July 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients diagnosed with essential hypertension

Exclusion Criteria:

patients who took Micardis Plus before participating in this PMS study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00659607

Responsible Party

Boehringer Ingelheim, Study Chair, Boehringer Ingelheim

Study ID Numbers ^ICMJE

502.475

Study Sponsor ^ICMJE

Boehringer Ingelheim Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

Information Provided By

Boehringer Ingelheim Pharmaceuticals

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP