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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)

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ClinicalTrials.gov 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
Sponsor:
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



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

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 ClinicalTrials.gov identifier (NCT number): NCT01426594


Contacts
Contact: Sandra M Casiano, MD 57-3174049763 scasiano@closterpharma.com
Contact: Harold Mejia 57-2264757 hmejia@closterpharma.com

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

Responsible Party: Closter Pharma
ClinicalTrials.gov 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:
Observational
Colombia
Metpure XL

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases