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CompletedNCT01109043Updated Jul 31, 2014

Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate

An observational study in Hypertension, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Austria. Open to participants aged Up to 54 Years. Per ClinicalTrials.gov, last updated 2014-07-31.

Sponsored by Merck KGaA, Darmstadt, Germany · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
351
Ages
Up to 54 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • Bisoprolol
  • Antihypertensive drugs
  • Blood pressure
  • Quality of life
  • Diabetes
  • Ketohexokinase
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 351 is above the median of 210 across 1,358 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 54 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hypertensive subjects

Inclusion criteria

  • Subjects with high blood pressure (BP) and tachycardia
  • Subjects with essential hypotonia, angina pectoris
  • Subjects with essential hypertonia, when a therapy with ß-blockers or diuretics is not sufficiently effective
  • Precautions to be taken in case of severe peripheral circulation disorders, diabetes (especially at the time, when blood sugar is elevated), during a strict fast, in case of metabolic acidosis, atrioventricular block (AV) block of grade I, Prinzmetal angina, additional therapy with angiotensin-converting enzyme inhibitors (ACE-inhibitors), severe coronary or cerebral sclerosis, hyperuricemia or gout and in subjects with a history of severe hypersensitive reactions or during a desensitization therapy (excessive anaphylactic reaction, attenuated adrenergic counterregulation)
  • Special precautions must be taken with the subjects that have a family history or suffered from psoriasis, during a desensitization therapy (also anamnestic subjects), other obstructive pulmonary diseases on account of the possibility of initiation or intensification of bronchoconstriction, although, due to the marked ß1-selectivity of bisoprolol, the risk is lower than with non-selective ß-receptor blockers. The subjects that have a family history or suffered from psoriasis should the take Concor Plus only after a careful assessment of risk - benefit ratio. The subjects with pheochromocytoma should take Concor Plus, as well as other ß-blockers after inhibiting the alpha-receptors

Exclusion criteria

Exclusion Criteria:

  • Subjects with acute cardiac insufficiency, sinus sick syndrome, bradycardia and anaemia
  • Contraindicated medical conditions for bisoprolol as defined in the Product Information, i.e. a known hypersensitivity to the active agent bisoprolol or one of the inactive ingredients of the medication; acute heart failure or decompensation of heart insufficiency, that requires a therapy with inotropic agents; cardiogenic shock; AV block grade II or III (in the absence of cardiac pacemakers); sick sinus syndrome, sinoatrial heart block; symptomatic bradycardia; symptomatic hypotonia; severe asthma bronchiolus or severe chronic obstructive airways disease; advanced stages of peripheral arterial disease or Raynaud's Syndrome; untreated pheochromocytoma, metabolic acidosis
  • Contraindicated medical conditions for bisoprolol + hydrochlorothiazide (HCTZ) as defined in the Product Information, i.e. hypersensitivity to the ingredients of the medication containing bisoprolol + HCTZ, uncompensated heart insufficiency, pulmonary hypertension, cardiogenic shock, AV block, grades II and III. sick sinus syndrome (in the absence of cardiac pacemakers), sinoatrial heart block, severe bradycardia with less than 50 beats/min from the start of treatment, hypotension(systolic less than 90 mmHg), acute asthmatic attack, intravenous administration of calcium antagonists of Verapamil type, simultaneous treatment with monoamine oxidase inhibitors (MAO-inhibitors), advanced stages of peripheral circulation disorder, severe therapy-resistant potassium deficiency, severe hyponatraemia, hypercalcaemia, severe renal dysfunction (serum creatinin over 1.8 mg/100 ml and/or creatinin clearance under 30 ml/min); acute glomerulonephritis; liver coma; children, not previously treated; pregnancy and breastfeeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
351 participants (actual)

Interventions

  • DrugBisoprolol 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

    Also known as: Concor or Concor Plus

06

What researchers measure

Primary outcomes

  1. Improvement in heart rate

    Time frame: Baseline to 6 months of therapy treatment

  2. Changes in systolic and diastolic BP

    Time frame: Baseline to 6 months of therapy treatment

Secondary outcomes

  1. Assessment of quality of life (SQ-8 Short Form Health Survey)

    Time frame: Beginning and at the end of 6 month therapy

07

Study locations

1 site
  • Merck Serono Research Site
    Vienna, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01109043
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborators
Merck Gesellschaft mbH, Austria
Responsible party
Sponsor
First posted
Apr 22, 2010
Start date
Jun 2009
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Jul 31, 2014

Study contacts

Bernhard List
study director · Merck Serono Austria a division of Merck Gesellschaft mbH, Austria, an affiliate of Merck KGaA, Darmstadt, Germany
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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