Trial to check efficacy and safety of Concor 5mg plus amlodipine 5mg in patients who have high blood pressure and whose blood pressure cannot be controlled under 5mg of amlodipine monotherapy.

Efficacy and safety of Concor 5mg plus amlodipine 5mg in hypertensive patients whose blood pressure cannot be controlled under 5mg of amlodipine monotherapy, a phase III multicentre, randomised, double-blind, clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000751-13-PL

Enrollment

400

Registered

2019-03-21

Start date

2019-07-02

Completion date

Unknown

Last updated

2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertension MedDRA version: 21.1 Level: PT Classification code 10015488 Term: Essential hypertension System Organ Class: 10047065 - Vascular disorders

Interventions

Product Name: Concor (bisoprolol) Pharmaceutical Form: Film-coated tablet Current Sponsor code: Concor 5 mg film-coated tablets Other descriptive name: BISOPROLOL FUMARATE Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Essential hypertension not controlled at 5mg amlodipine (treatment for at least 4 weeks) (definition of not controlled: SBP = 140mmHg with or without DBP = 90mmHg). •Male or female subjects = 18 years of age. •Medically accepted effective contraception if procreative potential exists (applicable for both male and female subjects until at least 90 days after the last dose of trial treatment). •Subjects who signed the informed consent form (ICF) before any trial-related assessment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: •Any contraindication to bisoprolol or amlodipine •Baseline heart rate <60 beats/min •Any other antihypertensive drugs (other than amlodipine) used within 4 weeks prior to Visit 1 •Pregnancy or lactation • Woman willing to become pregnant •Other significant disease that in the Investigator’s opinion excluded the subject from the trial, including but not limited to uncontrolled diabetes mellitus, severe liver, and/or kidney dysfunction, decompensated cardiac failure. •Any other condition or therapy, which in the Investigator’s opinion could have posed a risk to the subject or interfere with the trial objectives. •Participation in another clinical trial within the previous 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the superiority of Concor 5mg plus amlodipine 5mg over amlodipine 5mg monotherapy;Secondary Objective: To demonstrate efficacy and safety of the study drug in the target patient group;Primary end point(s): Systolic blood pressure (SBP) ;Timepoint(s) of evaluation of this end point: after 8 weeks of treatment compared to baseline	—

Secondary

Measure	Time frame
Secondary end point(s): 1. SBP after4 weeks of treatment compared to baseline, 2. Diastolic blood pressure (DBP) pressure after 4 and 8 weeks of treatment vs baseline 3. Heart (HR) rate after 4 and 8 weeks of treatment compared to baseline 4. Percentage of patients with blood pressure controlled after 4 and 8 weeks of treatment 5 Frequency and severity of adverse events ;Timepoint(s) of evaluation of this end point: 1. after 4 weeks of treatment compared to baseline, 2. after 4 and 8 weeks of treatment vs baseline 3. after 4 and 8 weeks of treatment compared to baseline 4. after 4 and 8 weeks of treatment 5. during the whole trial	—

Measure

Time frame

Secondary end point(s): 1. SBP after4 weeks of treatment compared to baseline, 2. Diastolic blood pressure (DBP) pressure after 4 and 8 weeks of treatment vs baseline 3. Heart (HR) rate after 4 and 8 weeks of treatment compared to baseline 4. Percentage of patients with blood pressure controlled after 4 and 8 weeks of treatment 5 Frequency and severity of adverse events ;Timepoint(s) of evaluation of this end point: 1. after 4 weeks of treatment compared to baseline, 2. after 4 and 8 weeks of treatment vs baseline 3. after 4 and 8 weeks of treatment compared to baseline 4. after 4 and 8 weeks of treatment 5. during the whole trial

—

Countries

Poland

Contacts

Public ContactZbigniew Gaciong

Department of Internal Medicine, Hypertension and Vascular Diseases The Medical University of Warsaw

+4822 599 28 28

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026