NCT01109043

Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate

b. p. m Study (Beats Per Minute): Heart Rate Development Whilst Treating Patients With Hypertension With Concor or Concor Plus

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 351 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 54 Years
• Healthy volunteers: Not accepted

Summary

The b.p.m study will be performed to gain the insight in the courses of illness and therapy in subjects, suffering from hypertension and that have elevated heart rate. This study will show that a therapy with bisoprolol (Concor/Concor PLUS) or any other blood pressure lowering (antihypertensive) drug lowers blood pressure (BP) and heart rate and increases the quality of subjects' life.

Detailed description

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).

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	Bisoprolol or bisoprolol + HCTZ	Film-coated tablets containing 5 mg or 10 mg of bisoprolol hemifumarate or film-coated tablets containing 5 mg of bisoprolol fumarate (2:1) and 12.5 mg of HCTZ were given

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-04-22
• Last updated: 2014-07-31

Locations

1 site across 1 country: Austria