CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 209 enrolled
Drug / intervention
Bisoprolol +1 moredrug
Likely dose
Bisoprolol 5 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01079962
NCT01079962Phase 4Completed

A Prospective, Multi-center, Randomized, Open-label, Clinical Trial to Compare the Aortic Pulse Pressure Effects of Bisoprolol and Atenolol in 12 Weeks Treatment of Hypertension

Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 3, 2010·Updated Feb 13, 2014

In Brief

A Phase 4 clinical trial evaluating Bisoprolol and Atenolol for Hypertension. Completed, enrolled 209 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesSouth Korea
CollaboratorsMerck Ltd.

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2010
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.3 years ago

Interventions

Bisoprololdrug

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

Atenololdrug

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