Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives
This study has been completed.
Sponsor:
Boehringer Ingelheim
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00539487
First received: September 25, 2007
Last updated: November 7, 2013
Last verified: November 2013
| Tracking Information | |||||
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| First Received Date ICMJE | September 25, 2007 | ||||
| Last Updated Date | November 7, 2013 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Blood pressure reduction [ Time Frame: 4 month ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00539487 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Change in metabolic parameters Safety [ Time Frame: n.a. ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Observational Non-interventional Study (Anwendungsbeobachtung) With Telmisartan in High-risk Hypertensives | ||||
| Official Title ICMJE | 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 |
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| Detailed Description | Study Design: |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | hypertensive patients |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 5827 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Germany | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00539487 | ||||
| Other Study ID Numbers ICMJE | 502.523, n.a. | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim, Study Chair, Boehringer Ingelheim | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim | ||||
| Verification Date | November 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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