NCT01426594UnknownNot Applicable
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
Closter Pharma1 site in 1 country2,000 target enrollmentStarted: August 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Effect of therapy in the management of cardiovascular diseases
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Evaluate and compare the rate of compliance with treatment(8 weeks)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(8 weeks)
Investigators
Study Sites (1)
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