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

NCT01213173 | Completed Phase 4 Results

• 1 other identifier: D4022L00008
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Angina Pectoris

Keywords

angina pectoris; chest pain; heart rate

Outcome Measures

Primary Outcomes (1)

• 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.

  After 8 weeks treatment in the study

Secondary Outcomes (12)

• The Impact on 24-hr Average Heart Rate From Baseline Within Groups

  After 8 weeks treatment in the study

• The Different Impact on 24-hr Average Heart Rate Between Two Groups

  After 2 weeks treatment in the study

• The Different Impact on 24-hr Average Heart Rate From Baseline Within Groups

  After 2 weeks treatment in the study

• The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups

  After 2 weeks treatment

• The Proportion of Patients With Resting Heart Rate Controlled to ≤60bpm Between Groups

  After 8 weeks treatment

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Succinate Metoprolol (Betaloc ZOK®)

2

EXPERIMENTAL

Drug: Succinate Metoprolol (Betaloc ZOK®)

Interventions

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

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (10)

Research Site

Beijing, Beijing Municipality, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Tangshan, Hebei, China

Location

Research Site

Zhengzhou, Henan, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Jingzhou, Liaoning, China

Location

Research Site

Shenyang, Liaoning, China

Location

Research Site

Shanghai, Shanghai Municipality, China

Location

Research Site

Taiyuan, Shanxi, China

Location

Research Site

Tianjing, China

Location

Related Links

• Related Info
• CSR-D4022L00008.pdf

MeSH Terms

Conditions

Angina Pectoris; Chest Pain

Interventions

Metoprolol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Limitations and Caveats

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.

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

+44 1625 518062

Study Officials

• Huo Yong

  Department of Cardiology, Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Helen Lin

  Astrazeneca China

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 5, 2014
• Results First Posted: August 26, 2013

Record last verified: 2014-08

Locations

CN (10)