An Active-controlled, Clinical Trial to Assess Central Hemodynamic Effects of Bisoprolol in Hypertensive Patients (Central Hemodynamic Assessment Measured in Patient With HypertensION [CHAMPION])

NCT01079962 | Completed Phase 4 Results

• 1 other identifier: EMD 084000-505
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

Brief Summary

Antihypertensive drugs aim to reduce blood pressure (BP) either through decrease of the total peripheral resistance through vasodilatation at the level of arterioles (microcirculation) or by decreasing the cardiac output through reduction of the stroke volume or heart rate or both. On the other hand, all antihypertensive drugs might potentially decrease arterial stiffness passively with the reduction of the distending pressure or with the resynchronization of the reflected pressure wave. With theses potential mechanisms, it is also expected that these drugs might exert a favorable effect on pulse pressure amplification between central and peripheral arteries. However, there is solid evidence that the widely applied antihypertensive drugs have differential effect on brachial and central BP. Several reports in the past have confirmed the potential hypothesis that beta blockers decrease central BP less than the observed reduction at the level of the brachial artery. It has been hypothesized that deceleration of heart rate and the re synchronizing the reflected pressure wave earlier in the systolic phase seems to be the leading cause of non-favorable effect of beta blockers on central BP, these effects might be partially counterbalanced in beta blockers with high beta-1 selectivity resulting in less peripheral vasoconstriction properties.

Conditions

Hypertension

Keywords

Bisoprolol; Atenolol; Hypertension; Blood pressure

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12

  The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.

  Baseline and Week 12

• Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12

  The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline.

  Baseline and Week 12

Secondary Outcomes (9)

• Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Heart Rate at Week 4 and Week 12

  Baseline, Week 4 and Week 12

• Change From Baseline in Aortic Pulse Pressure (APP) at Week 4

  Baseline and Week 4

Study Arms (2)

Bisoprolol

EXPERIMENTAL

Drug: Bisoprolol

Atenolol

ACTIVE COMPARATOR

Drug: Atenolol

Interventions

Bisoprolol DRUG

Bisoprolol tablet will be administered orally at a dose of 5 milligram (mg) once daily in the morning for 12 weeks.

Also known as: CONCOR®

Bisoprolol

Atenolol DRUG

Atenolol tablet will be administered orally at a dose of 50 mg once daily in the morning for 12 weeks.

Also known as: TENORMIN®

Atenolol

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An antihypertensive-naive subject or a subject who has not been taking the previously administered antihypertensive agent for at least 4 weeks prior to screening
• Subjects aged between 20 and 75 years, inclusive
• Subjects with systolic blood pressure (SBP) greater than or equal to 140 millimeter of mercury (mmHg) and less than 180 mmHg or diastolic blood pressure (DBP) greater than or equal to 90 mmHg and less than 110 mmHg

You may not qualify if:

• Subjects with secondary hypertension
• Subjects with renal impairment (Creatinine greater than 150 micromoles/liter \[mcmol/L\] or Creatinine greater than 1.7 mg/deciliter \[dL\])
• Subjects with severe hypertension (Stage III) SBP greater than or equal to 180 mmHg or DBP greater than or equal to 110 mmHg
• Subjects with congestive heart failure, acute myocardial infarction, unstable angina
• Subjects with moderate bronchial asthma, chronic obstructive pulmonary disease
• Subjects with symptomatic bradycardia, radial artery injury, second degree or third degree atrioventricular (AV) block, atrial fibrillation, atrial flutter, left bundle branch block (LBBB)
• Subjects with a history of hypersensitivity to bisoprolol and atenolol products
• Pregnancy or breastfeeding women

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Ltd.: collaborator

Study Sites (1)

Severance Hosptial, 250, Seongsanno, Seodaemungu

Seoul, South Korea

Location

Related Publications (1)

• Park S, Rhee MY, Lee SY, Park SW, Jeon D, Kim BW, Kwan J, Choi D. A prospective, randomized, open-label, active-controlled, clinical trial to assess central haemodynamic effects of bisoprolol and atenolol in hypertensive patients. J Hypertens. 2013 Apr;31(4):813-9. doi: 10.1097/HJH.0b013e32835e8f5b.

  PMID: 23385648 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Bisoprolol; Atenolol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Ltd., Korea, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 13, 2014
• Results First Posted: October 2, 2012

Record last verified: 2014-01

Locations

KR (1)