Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance
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| First Received Date ICMJE | August 29, 2005 | ||||||||
| Last Updated Date | August 29, 2007 | ||||||||
| Start Date ICMJE | October 2003 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in 24-hour systolic blood pressure from baseline to 1 year | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00139984 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance | ||||||||
| Official Title ICMJE | Impact of Ambulatory Blood Pressure Monitoring for Antihypertensive Treatment Guidance in Medical Outpatients: The Hyper-ABC Study | ||||||||
| Brief Summary | The purpose of this study is to determine whether in patients with arterial hypertension, treatment guidance using 24-hour blood pressure measurement results in better blood pressure control compared to treatment guidance using office blood pressure measurement. |
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| Detailed Description | Blood pressure control in arterial hypertension remains poor, despite the availability of effective drug treatment. Therefore, strategies to increase blood pressure control are urgently needed. 24 hour blood pressure is a better predictor of cardiovascular morbidity and mortality than office blood pressure. Furthermore, the lower variability of measurements over time of 24 hour blood pressure could allow better adjustment of antihypertensive therapy. However, there are only scarce data about antihypertensive treatment adjustment using 24 hour blood pressure instead of office blood pressure. Aim: To test the hypothesis that a 24 hour blood pressure guided therapy is is more effective in reaching blood pressure control when compared to conventional office blood pressure guided therapy. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Hypertension | ||||||||
| Intervention ICMJE | Device: 24 hour blood pressure measurement | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | Conen D, Tschudi P, Martina B. Twenty-four hour ambulatory blood pressure for the management of antihypertensive treatment: a randomized controlled trial. J Hum Hypertens. 2009 Feb;23(2):122-9. Epub 2008 Aug 28. | ||||||||
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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 | ||||||||
| Estimated Enrollment ICMJE | 170 | ||||||||
| Completion Date | May 2007 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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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 | ||||||||
| Location Countries ICMJE | Switzerland | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00139984 | ||||||||
| Other Study ID Numbers ICMJE | EKBB183/03 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | University Hospital, Basel, Switzerland | ||||||||
| Collaborators ICMJE | Bayer | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Basel, Switzerland | ||||||||
| Verification Date | July 2007 | ||||||||
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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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