Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate
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|ClinicalTrials.gov Identifier: NCT01109043|
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : July 31, 2014
|Condition or disease||Intervention/treatment|
|Hypertension||Drug: Bisoprolol or bisoprolol + HCTZ|
The b.p.m study measures heart rate development whilst treating subjects with hypertension with Concor [bisoprolol] or Concor Plus [bisoprolol + hydrochlorothiazide (HCTZ)].
The objectives of this study are:
After 6 months of the therapy treatment, 60% of the subjects showed a heart rate ≥ 80 beats/min.
An improved quality of life information after 6 months of therapy treatment, collected by asking standardised questions A decrease in systolic and diastolic BP after 6 months presented significant differences Digital sphygmomanometers (BP measuring devices) will be supplied in order to document the values of BP and heart rate. Blood pressure and heart rate should be measured at least 2 times, ideally 4 times per day. Furthermore, every subject will additionally receive a documentation sheet, where he/she will record the measurement data. The documentation sheet will be a part of the improvement of the quality of life; it can be removed and passed on.
Every subject will be explained how to use and handle the BP measuring device and the importance of the documentation. The assessment of the quality of life must be made at the beginning and at the end of 6 month therapy. Within the framework of the examination the attending physician will ask 8 standard questions (SQ-8 Short Form Health Survey). The questionnaire will be a part of the quality of life assessment.
The main focus of the observation is on the age group < 55 years with concomitant diseases, such as diabetes or ketohexokinase (KHK).
|Study Type :||Observational|
|Actual Enrollment :||351 participants|
|Official Title:||b. p. m Study (Beats Per Minute): Heart Rate Development Whilst Treating Patients With Hypertension With Concor or Concor Plus|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Drug: Bisoprolol or bisoprolol + HCTZ
- Improvement in heart rate [ Time Frame: Baseline to 6 months of therapy treatment ]
- Changes in systolic and diastolic BP [ Time Frame: Baseline to 6 months of therapy treatment ]
- Assessment of quality of life (SQ-8 Short Form Health Survey) [ Time Frame: Beginning and at the end of 6 month therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109043
|Merck Serono Research Site|
|Study Director:||Bernhard List||Merck Serono Austria a division of Merck Gesellschaft mbH, Austria, an affiliate of Merck KGaA, Darmstadt, Germany|