At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 200 enrolled

Drug / intervention

Bisoprolol/Amlodipine (Bisoprolol failed group) +1 moredrug

Likely dose

Bisoprolol/Amlodipine (Bisoprolol failed group) 5 mgfrom 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/NCT01977794

NCT01977794Phase 3Completed

Compare CT.gov

A Randomized, Comparative Trial of Concor AM, a Fixed Dose Combination of Bisoprolol and Amlodipine, on the Treatment of Essential Hypertensive Patients Whose Blood Pressure is Not Well Controlled by Monotherapy of Bisoprolol 5mg or Amlodipine 5mg

Merck KGaA, Darmstadt, Germany·interventional·Posted Nov 7, 2013·Updated Jan 30, 2017

In Brief

A Phase 3 clinical trial evaluating Bisoprolol/Amlodipine (Bisoprolol failed group) and Bisoprolol/Amlodipine (Amlodipine failed group) for Hypertension. Completed, enrolled 200 participants across 1 site.

Detailed Summary

This is a randomized, comparative Phase 3 trial to investigate the efficacy of fixed dose combination (FDC) of bisoprolol and amlodipine in hypertensive subjects (superiority of FDC over monotherapies).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsHypertension

CountriesGermany

Collaborators--

Timeline

Phase 3CompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedNov 2013

Enrollment StartMar 2014

Primary CompletionMar 2015

TodayJul 2026

First PostedNov 7, 2013

Enrollment StartMar 1, 2014

Primary CompletionMar 1, 2015

TodayJul 2, 2026

Enrollment to primary: 1 yearPosted 12.7 years ago

Interventions

Bisoprolol/Amlodipine (Bisoprolol failed group)drug

Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If blood pressure (BP) is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).

Bisoprolol/Amlodipine (Amlodipine failed group)drug

Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 milligram (mg)/5 mg once daily for 6 weeks. If BP is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).