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)
This study is currently recruiting participants.
Verified August 2011 by Closter Pharma
Sponsor:
Closter Pharma
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
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Purpose
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 |
|---|
|
Hypertension Coronary Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
Resource links provided by NLM:
Further study details as provided by Closter Pharma:
Primary Outcome Measures:
- 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
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: | 2000 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
More Information
No publications provided
| Responsible Party: | Closter Pharma |
| ClinicalTrials.gov Identifier: | NCT01426594 History of Changes |
| Other Study ID Numbers: | COL-CARDIO-NIS002 |
| Study First Received: | August 29, 2011 |
| Last Updated: | August 30, 2011 |
| Health Authority: | Colombia: INVIMA |
Keywords provided by Closter Pharma:
|
Observational Colombia Metpure XL |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Coronary Disease Coronary Artery Disease Hypertension Myocardial Ischemia Heart Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013