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Real-life Experience of the Use of Isomers as METPURE XL (S (-) Metoprolol Succinate) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients (XPERT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Closter Pharma.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Closter Pharma Identifier:
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011
This is a Phase 4, observational, open study in patients who their doctor has prescribe METPURE XL (S (-)metoprolol succinate)by clinical practice. No medication was provided by the sponsor. The planned observation time is 8 weeks. The 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8.

Coronary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Closter Pharma:

Primary Outcome Measures:
  • Effect of therapy in the management of cardiovascular diseases [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The objective is to mesure the effect of Metpure XL in cadiovascular diseases as hypertension, post MI and coronary disease

Secondary Outcome Measures:
  • Evaluate and compare the rate of compliance with treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Evaluate the compliance with METPURE XL, to be able to identify possible reasons for noncompliance or quitting the treatment

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety pattern in Colombian subjects using s(-)metoprolol succinate

Estimated Enrollment: 2000
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care adults

Inclusion Criteria:

  • Patients who were prescibed with s(-)metoprolol succinate(25mg, 50mg), depending on their clinical condition and use locally approved will be eligible to participate in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01426594

Contact: Sandra M Casiano, MD 57-3174049763
Contact: Harold Mejia 57-2264757

Country Club de Bogota Recruiting
Bogota, Colombia
Principal Investigator: Andres Romero, MD         
Sponsors and Collaborators
Closter Pharma
  More Information

Responsible Party: Closter Pharma Identifier: NCT01426594     History of Changes
Other Study ID Numbers: COL-CARDIO-NIS002 
Study First Received: August 29, 2011
Last Updated: August 30, 2011
Health Authority: Colombia: INVIMA

Keywords provided by Closter Pharma:
Metpure XL

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016