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):
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.
||Time Perspective: Prospective
Primary Outcome Measures:
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01426594
|Country Club de Bogota
|Bogota, Colombia |
|Principal Investigator: Andres Romero, MD |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 29, 2011
||August 30, 2011
Keywords provided by Closter Pharma:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 22, 2014
Coronary Artery Disease
Arterial Occlusive Diseases