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
Sponsor:
Information provided by (Responsible Party):
Closter Pharma
ClinicalTrials.gov Identifier:
NCT01426594
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011

August 29, 2011
August 30, 2011
August 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01426594 on ClinicalTrials.gov Archive Site
  • 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
Same as current
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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
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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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Primary care adults

  • Hypertension
  • Coronary Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
March 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Sandra M Casiano, MD 57-3174049763 scasiano@closterpharma.com
Contact: Harold Mejia 57-2264757 hmejia@closterpharma.com
Colombia
 
NCT01426594
COL-CARDIO-NIS002
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Closter Pharma
Closter Pharma
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Closter Pharma
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP