HypertensionPhase 4NCT01251146

A Randomized Controlled Study to Assess the Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Subjects With Essential Hypertension

A Phase 4 study testing Bisoprolol and Atenolol in people with Hypertension, run by Merck KGaA, Darmstadt, Germany at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase 4, prospective, multi-centric and randomized controlled study to compare the effects of bisoprolol and atenolol on resting heart rate (RHR) and sympathetic nervous system's (SNS) activity in subjects with essential hypertension. Read more about this study

Who is it for?: Ages 25 to 65 years
Conditions the study is for: Hypertension
What is being tested?: Bisoprolol and Atenolol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 177 participants
Where: 2 sitesChina
Study dates: Nov 2010to Feb 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects aged between 25-65 years
Subjects with essential hypertension (EH)
Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
Subjects with normal sinus rhythm
Subjects with resting heart rate (RHR) greater than 70 bpm
Subjects who give written informed consent

Who cannot join

Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
Subjects with bradyarrhythmia/hypotension
Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association [NYHA] Class III - IV)
Subjects with uncontrolled diabetes mellitus (DM)
Subjects with bronchial asthma
Subjects with gastro-intestinal ulcer or skin ulcer

Show all 13Show fewer

Subjects with liver dysfunction/renal impairment
Subjects treated with calcium channel blockers (except amlodipine) or other beta-blockers.
Subjects with glaucoma
Subjects with known allergic/intolerance to beta-blocker
Pregnant or lactating women
Subjects who had participated in another clinical study within the last 3 months
Subjects who have legal incapacity or limited legal capacity

Trial locations and contacts

2 sites in 1 country.

China2 sites

Beijing Shi Jingshan Hospital
Beijing
Shanghai Institute of Hypertension
Shanghai

Other trials in China

About this study

Official title: Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension

Conditions: Hypertension
Being tested: Bisoprolol, Atenolol
Keywords: Hypertension, Bisoprolol, Atenolol
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BisoprololDrug
Also called Concor®
Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.
AtenololDrug
Atenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.

Study groups in NCT01251146
Study group	Role	What they receive
Bisoprolol	Experimental	Not described Receives: Drug: Bisoprolol
Atenolol	Active comparator	Not described Receives: Drug: Atenolol

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).
Measured: Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up
Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Measured: Baseline and end of follow-up (Week 4 or Week 6 or Week 8)

Secondary outcomes (6)

Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up
Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Measured: Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up
Heart rate variability (HRV) is used to describe the variations of both instantaneous HR and resting rate (RR) intervals and was evaluated for low frequency power (LF) and for high frequency power (HF). Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Measured: Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment
Dosage 1, 2 and 3 for bisoprolol group was defined as 5 mg, 7.5 mg and 10 mg once daily and for atenolol group as 50 mg, 75 mg and 100 mg once daily, respectively. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Measured: Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6
Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.
Measured: Attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: Any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition
Measured: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Number of Participants Compliant With Study Treatment
Participants compliant with study treatment were the participants who have completed the study treatment regimen.
Measured: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Feb 2012

First posted1 Dec 2010 (estimated)
Study startNov 2010
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 177 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01251146
Sponsor's protocol ID: EMR200006-515
Status last verified: Jan 2017
First submitted: 30 Nov 2010
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Bisoprolol and Atenolol on Resting Heart Rate and Sympathetic Nervous System's Activity in Patients With Essential Hypertension
ClinicalTrials.gov ID: NCT01251146
Acronym / sponsor ID: EMR200006-515
Conditions: Hypertension
Keywords: Hypertension, Bisoprolol, Atenolol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 177 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Collaborators: Merck Serono Co., Ltd., China
Study start: Nov 2010
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 1 Dec 2010 (estimated)
Results: Posted 30 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Bisoprolol	Experimental	Drug: Bisoprolol
Atenolol	Active comparator	Drug: Atenolol

Who may qualify

Ages: 25 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Subjects aged between 25-65 years
Subjects with essential hypertension (EH)
Subjects with systolic blood pressure (SBP) 140-160 millimeter of mercury (mmHg) and diastolic blood pressure (DBP) 90-100 mmHg
Subjects with normal sinus rhythm
Subjects with resting heart rate (RHR) greater than 70 bpm

Key exclusion criteria (13 listed)

Subjects with atrial fibrillation (AF)/sick sinus syndrome (SSS)/atrioventricular block II-III Grade (AVB II-III) without pacemaker
Subjects with bradyarrhythmia/hypotension
Subjects with unstable angina pectoris (UAP)/acute myocardial infarction (AMI)/heart failure (HF) (New York Heart Association [NYHA] Class III - IV)
Subjects with uncontrolled diabetes mellitus (DM)
Subjects with bronchial asthma

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BisoprololAlso: Concor®Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.	Drug	Bisoprolol
AtenololAtenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.	Drug	Atenolol

Primary outcome

Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal
Time frame: Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 beats per minute (bpm).
Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up
Time frame: Baseline and end of follow-up (Week 4 or Week 6 or Week 8)
Baroreflex sensitivity (BRS) is an important characteristic of baroreflex control and often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Heart rate goal was defined as attainment of heart rate less than or equal to 65 bpm.

6 secondary outcomes

Change From Baseline in Heart Rate Variability (HRV) for Low Frequency Power (LF) and for High Frequency Power (HF) at Attainment of Heart Rate Goal and End of Follow-up
Time frame: Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
Change From Baseline in Ratio of Heart Rate Variability (HRV) for Low Frequency Power (LF) to Heart Rate Variability Power (HRV) for High Frequency (HF) (LF/HF) at Attainment of Heart Rate Goal and End of Follow-up
Time frame: Baseline, attainment of heart rate goal (Week 2 or Week 4 or Week 6) and end of follow-up (Week 4 or Week 6 or Week 8)
Number of Participants Attaining Heart Rate Goal at Dosage 1, 2 and 3 of Study Treatment
Time frame: Baseline up to attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Percentage of Participants Attaining Heart Rate Goal at Week 2, 4 and 6
Time frame: Attainment of heart rate goal (Week 2 or Week 4 or Week 6)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)
Number of Participants Compliant With Study Treatment
Time frame: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8)

Results and safety

Results posted to the registry on 30 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bisoprolol	86	83
Atenolol	91	81

Primary outcome: Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal

Time frame: Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6). Mean (Standard Deviation). Unit: millisecond per millimeter of mercury

Measure	Bisoprolol n = 75	Atenolol n = 79
Baseline (n=75,79)	7.78 (2.92)	7.92 (3.26)
Change at attainment of heart rate goal (n=67,66)	3.27 (3.67)	2.88 (4.05)

Population analysed: Intention to treat (ITT) population included all randomized participants who received at least 1 dose of study medication. "N" signifies those participants who were evaluated for this measure. "n" signifies those participants who were evaluated for this measure at the specified time point for each treatment arm group respectively.

Primary outcome: Change From Baseline in Baroreflex Sensitivity (BRS) at End of Follow-up

Time frame: Baseline and end of follow-up (Week 4 or Week 6 or Week 8). Mean (Standard Deviation). Unit: millisecond per millimeter of mercury

Measure	Bisoprolol n = 71	Atenolol n = 66
Value	4.08 (3.79)	3.31 (3.83)

Population analysed: ITT population included all randomized participants who received at least 1 dose of study medication. "N" signifies those participants who were evaluated for this measure.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to end of follow-up (Week 4 or Week 6 or Week 8). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bisoprolol	0 of 86 (0%)	6 of 86 (7%)	Not reported
Atenolol	0 of 91 (0%)	6 of 91 (6.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gao Pingjin, Prof. principal investigator

Shanghai Institute of Hypertension

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bisoprolol and Atenolol in people with Hypertension, run by Merck KGaA, Darmstadt, Germany at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Baroreflex Sensitivity (BRS) at Attainment of Heart Rate Goal (time frame: Baseline and attainment of heart rate goal (Week 2 or Week 4 or Week 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01251146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.