Angina PectorisPhase 4NCT01213173

Evaluation of Succinate Metoprolol on Heart Rate in the Stable Angina Patients

A Phase 4 study testing Succinate Metoprolol (Betaloc ZOK®) in people with Angina Pectoris, run by AstraZeneca at 10 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

The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Angina Pectoris
What is being tested?: Succinate Metoprolol (Betaloc ZOK®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 251 participants
Where: 10 sitesChina
Study dates: Oct 2010to Sep 2011
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent prior to any study specific procedures
Chinese patients
Heart rate ≥ 65bpm
Has been diagnosed as Stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose criteria of Stable angina on Appendix C)
With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;
Has been on beta-blockers for at least 4 weeks*, on the dose equivalent to Betaloc ZOK® 23.75-47.5mg/day.

Who cannot join

Acute myocardial infarction within 6 months
Unstable angina or Prinzmetal's angina
II degree of AV block or greater
Significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the Investigator's opinion) including:
Significant renal impairment (serum creatinine > 2.0 mg/dL)
Serum Alanine Aminotransferase or Aspartate Aminotransferase > 3 x upper limit of reference range

Show all 12Show fewer

Serum potassium < 3.0 mEq/L
Serum sodium ≤ 130 mEq/L
Acute or chronic hepatitis or cirrhosis (clinical diagnosis)
Uncontrolled hyperthyroidism (clinical diagnosis)
Systolic blood pressure ≥ 180 mmHg, or < 100mmHg at enrolment
Patients with unstable, not compensated heart failure (pulmonary oedema, hypoperfusion or hypotension)

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

China10 sites

Research Site
Beijing, Beijing Municipality
Research Site
Guangzhou, Guangdong
Research Site
Jingzhou, Liaoning
Research Site
Nanjing, Jiangsu
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Taiyuan, Shanxi
Research Site
Tangshan, Hebei
Research Site
Tianjing
Research Site
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Randomised, Open Label, Parallel Group, Multicentre, Phase IV Study on the Effect of 8 Weeks Succinate Metoprolol (Betaloc ZOK®) (95 - 190 mg) on Heart Rate in the Stable Angina Patients

The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.

Conditions: Angina Pectoris
Being tested: Succinate Metoprolol (Betaloc ZOK®)
Keywords: angina pectoris, chest pain, heart rate
Medical subject headings: Angina Pectoris, Chest Pain

What participants receive

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

Succinate Metoprolol (Betaloc ZOK®)Drug
treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
Succinate Metoprolol (Betaloc ZOK®)Drug
Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks

Study groups in NCT01213173
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Succinate Metoprolol (Betaloc ZOK®)
2	Experimental	Not described Receives: Drug: Succinate Metoprolol (Betaloc ZOK®)

What is being measured

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

The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)
Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.
Measured: After 8 weeks treatment in the study

Secondary outcomes (12)

The Impact on 24-hr Average Heart Rate From Baseline Within Groups
Difference of the 24-hr average heart rate within groups from baseline after 8 weeks treatment.
Measured: After 8 weeks treatment in the study
The Different Impact on 24-hr Average Heart Rate Between Two Groups
Difference of the 24-hr average heart rate between two groups after 2 weeks of treatment.
Measured: After 2 weeks treatment in the study
The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups
Difference of the 24-hr average heart rate within groups from baseline after 2 weeks treatment.
Measured: After 2 weeks treatment in the study
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 2 weeks treatment between groups
Measured: After 2 weeks treatment
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
Difference in proportions of patients who had resting heart rate controlled to ≤60 bpm after 8 weeks treatment between groups
Measured: After 8 weeks treatment
The Difference of Change From Baseline in Total Ischemic Burden Between Groups
Difference in change from baseline in TIB between two groups after 2 weeks treatment.
Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc).
Measured: After 2 weeks treatment
The Difference of Change From Baseline in Total Ischemic Burden Between Groups
Difference in change from baseline in TIB between two groups after 8 weeks treatment.
Total Ischemic Burden (TIB) was defined as the sum of product of each ischemia episode lasting time and maximal ST elevation: TIB=Σ(STmax×Tisc).
Measured: After 8 weeks treatment
The Difference of Change From Baseline in Angina Frequency Between Groups
Difference in change from baseline of angina pectoris frequency between two groups after 2 weeks treatment.
Measured: After 2 weeks treatment
The Difference of Change From Baseline in Angina Frequency Between Groups
Difference in change from baseline of angina pectoris frequency between two groups after 8 weeks treatment.
Measured: After 8 weeks treatment
The Change From Baseline in Total Cholesterol
Difference of change from baseline in TC after 8 weeks treatment between groups.
Measured: After 8 weeks treatment
The Change From Baseline in Fasting Plasma Glucose
Difference of change from baseline in FPG after 8 weeks treatment between groups.
Measured: After 8 weeks treatment
The Change From Baseline in Triglycerides
Difference of change from baseline in TG after 8 weeks treatment between groups.
Measured: After 8 weeks treatment

Timeline

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

Oct 2010Sep 2011

First posted1 Oct 2010 (estimated)
Study startOct 2010
Primary completionSep 2011
Study completionSep 2011

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 Angina PectorisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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: 251 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01213173
Sponsor's protocol ID: D4022L00008
Status last verified: Aug 2014
First submitted: 30 Sep 2010
Last updated: 5 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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All Angina Pectoris trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Open Label, Parallel Group, Multicentre, Phase IV Study on the Effect of 8 Weeks Succinate Metoprolol (Betaloc ZOK®) (95 - 190 mg) on Heart Rate in the Stable Angina Patients
ClinicalTrials.gov ID: NCT01213173
Acronym / sponsor ID: D4022L00008
Conditions: Angina Pectoris
Keywords: angina pectoris, chest pain, heart rate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 251 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 1 Oct 2010 (estimated)
Results: Posted 26 Aug 2013

Clinical summary

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

The purpose of this study is to evaluate the effects of Succinate Metoprolol(Betaloc ZOK®) (95 - 190 mg) on heart rate in the Stable angina patients.

Study design

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

Arm	Type	Receives
1	Active comparator	Drug: Succinate Metoprolol (Betaloc ZOK®)
2	Experimental	Drug: Succinate Metoprolol (Betaloc ZOK®)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Provision of informed consent prior to any study specific procedures
Chinese patients
Heart rate ≥ 65bpm
Has been diagnosed as Stable angina for at least 1 month and with stable angina pectoris symptoms within 2 weeks previous to enrolment(Please find the diagnose criteria of Stable angina on Appendix C)
With Left ventricular ejection fraction ≥ 50% according to ultrasound cardiogram;

Key exclusion criteria (12 listed)

Acute myocardial infarction within 6 months
Unstable angina or Prinzmetal's angina
II degree of AV block or greater
Significant clinical, laboratory or electrocardiographic abnormalities that would place the subject at undue risk (in the Investigator's opinion) including:
Significant renal impairment (serum creatinine > 2.0 mg/dL)

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
Succinate Metoprolol (Betaloc ZOK®)treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks	Drug	1
Succinate Metoprolol (Betaloc ZOK®)Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks	Drug	2

Primary outcome

The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)
Time frame: After 8 weeks treatment in the study
Difference of the 24-hr average heart rate between two groups after 8 weeks treatment.

12 secondary outcomes

The Impact on 24-hr Average Heart Rate From Baseline Within Groups
Time frame: After 8 weeks treatment in the study
The Different Impact on 24-hr Average Heart Rate Between Two Groups
Time frame: After 2 weeks treatment in the study
The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups
Time frame: After 2 weeks treatment in the study
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
Time frame: After 2 weeks treatment
The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups
Time frame: After 8 weeks treatment
The Difference of Change From Baseline in Total Ischemic Burden Between Groups
Time frame: After 2 weeks treatment
The Difference of Change From Baseline in Total Ischemic Burden Between Groups
Time frame: After 8 weeks treatment
The Difference of Change From Baseline in Angina Frequency Between Groups
Time frame: After 2 weeks treatment
The Difference of Change From Baseline in Angina Frequency Between Groups
Time frame: After 8 weeks treatment
The Change From Baseline in Total Cholesterol
Time frame: After 8 weeks treatment
The Change From Baseline in Fasting Plasma Glucose
Time frame: After 8 weeks treatment
The Change From Baseline in Triglycerides
Time frame: After 8 weeks treatment

Results and safety

Results posted to the registry on 26 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Comparator	125	113
Experimental	126	110

Primary outcome: The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg)

Time frame: After 8 weeks treatment in the study. Mean (Standard Deviation). Unit: Bpm

Measure	Arm 1 - Active Comparator n = 116	Arm 2 - Experimental n = 115
Baseline	71.4 (8.02)	70.9 (8.19)
Week 9	70.9 (8.71)	68.6 (8.40)

Population analysed: ITT population was defined as all randomized subjects who had taken at least one dose of trial treatment, who had measurements at baseline for one or more efficacy variables and at least one post baseline measurement for the same variables in the treatment period.

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Comparator	1 of 139 (0.7%)	0 of 139 (0%)	Not reported
Experimental	3 of 112 (2.7%)	0 of 112 (0%)	Not reported

Limitations and caveats (from the sponsor): The sample size was insufficient for the secondary endpoints. Besides, the treatment prior to study did not correlate well with 47.5 mg metoprolol succinate, but with some higher dose. last the quality control of the study needs further improvement.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
CSR-D4022L00008.pdfLink provided by the sponsor.

Related trials for Angina Pectoris

RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
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Recruiting
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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.

Huo Yong principal investigator

Department of Cardiology, Peking University First Hospital

Helen Lin study director

Astrazeneca China

10 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 Succinate Metoprolol (Betaloc ZOK®) in people with Angina Pectoris, run by AstraZeneca at 10 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 12 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 26 Aug 2013). 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?

The Impact on 24-hr Average Heart Rate Between Two Groups (Betaloc ZOK® 95mg vs. 190mg) (time frame: After 8 weeks treatment in the study). 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 NCT01213173.

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 5 Sep 2014.