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Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00539487
Recruitment Status : Completed
First Posted : October 4, 2007
Last Update Posted : November 8, 2013
Sponsor:
Information provided by:
Boehringer Ingelheim

Tracking Information
First Submitted Date September 25, 2007
First Posted Date October 4, 2007
Last Update Posted Date November 8, 2013
Study Start Date January 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 8, 2009)
Blood pressure reduction [ Time Frame: 4 month ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 8, 2009)
Change in metabolic parameters Safety
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives
Official Title TOP -Study Telmisartan - Therapy of Hypertension and Life-style Changes in Cardiovascular Risk Patients
Brief Summary This observational non-interventional study will assess (under conditions of clinical practice in daily routine) the antihypertensive efficacy of telmisartan treatment with or without active promotion of lifestyle changes in hypertensive patients at high cardiovascular risk
Detailed Description Study Design:
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population hypertensive patients
Condition
  • Hypertension
  • Obesity
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2009)
5827
Original Enrollment
 (submitted: October 3, 2007)
10000
Study Completion Date Not Provided
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus.

Exclusion Criteria:

according to SPC

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00539487
Other Study ID Numbers 502.523
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Original Responsible Party Not Provided
Current Study Sponsor Boehringer Ingelheim
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date November 2013