Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives
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ClinicalTrials.gov Identifier: NCT00539487 |
Recruitment Status :
Completed
First Posted : October 4, 2007
Last Update Posted : November 8, 2013
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Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
Tracking Information | ||||
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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 |
Blood pressure reduction [ Time Frame: 4 month ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures |
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 |
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
5827 | |||
Original Enrollment |
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 |
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Sex/Gender |
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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 |
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PRS Account | Boehringer Ingelheim | |||
Verification Date | November 2013 |