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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01426594
Recruitment Status : Unknown
Verified August 2011 by Closter Pharma.
Recruitment status was:  Recruiting
First Posted : August 31, 2011
Last Update Posted : August 31, 2011
Information provided by (Responsible Party):
Closter Pharma

Brief Summary:
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.

Condition or disease
Hypertension Coronary Disease

Study Type : Observational
Estimated Enrollment : 2000 participants
Time Perspective: Prospective
Study Start Date : August 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : March 2012

Primary Outcome Measures :
  1. Effect of therapy in the management of cardiovascular diseases [ Time Frame: 8 weeks ]
    The objective is to mesure the effect of Metpure XL in cadiovascular diseases as hypertension, post MI and coronary disease

Secondary Outcome Measures :
  1. Evaluate and compare the rate of compliance with treatment [ Time Frame: 8 weeks ]
    Evaluate the compliance with METPURE XL, to be able to identify possible reasons for noncompliance or quitting the treatment

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Closter Pharma Identifier: NCT01426594     History of Changes
Other Study ID Numbers: COL-CARDIO-NIS002
First Posted: August 31, 2011    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

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