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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01426594
Acronym
XPERT
Enrollment
2000
Registered
2011-08-31
Start date
2011-08-31
Completion date
2012-03-31
Last updated
2011-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Hypertension

Keywords

Observational, Colombia, Metpure XL

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.

Interventions

None listed

Sponsors

Closter Pharma
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of therapy in the management of cardiovascular diseases8 weeksThe objective is to mesure the effect of Metpure XL in cadiovascular diseases as hypertension, post MI and coronary disease

Secondary

MeasureTime frameDescription
Evaluate and compare the rate of compliance with treatment8 weeksEvaluate 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 Tolerability8 weeksTo assess the safety pattern in Colombian subjects using s(-)metoprolol succinate

Countries

Colombia

Contacts

Primary ContactSandra M Casiano, MD
scasiano@closterpharma.com57-3174049763
Backup ContactHarold Mejia
hmejia@closterpharma.com57-2264757

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026