Bisoprolol in Hypertension: Effect on Concomitant Elevated Heart Rate

NCT01109043 | Completed

• 1 other identifier: 084000-504
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Bisoprolol; Antihypertensive drugs; Blood pressure; Quality of life; Diabetes; Ketohexokinase

Outcome Measures

Primary Outcomes (2)

• Improvement in heart rate

  Baseline to 6 months of therapy treatment

• Changes in systolic and diastolic BP

  Baseline to 6 months of therapy treatment

Secondary Outcomes (1)

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

  Beginning and at the end of 6 month therapy

Interventions

Bisoprolol or bisoprolol + HCTZ DRUG

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

Eligibility Criteria

• Age: Up to 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Hypertensive subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Gesellschaft mbH, Austria: collaborator

Study Sites (1)

Merck Serono Research Site

Vienna, Austria

Location

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Interventions

Bisoprolol; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bernhard List

  Merck Serono Austria a division of Merck Gesellschaft mbH, Austria, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 22, 2010
• Study Start: June 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: July 31, 2014

Record last verified: 2011-11

Locations

AU (1)