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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 29, 2011 | ||||||||
| Last Updated Date | August 30, 2011 | ||||||||
| Start Date ICMJE | August 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01426594 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | 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 | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Primary care adults |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 2000 | ||||||||
| Estimated Completion Date | March 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Colombia | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01426594 | ||||||||
| Other Study ID Numbers ICMJE | COL-CARDIO-NIS002 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Closter Pharma | ||||||||
| Study Sponsor ICMJE | Closter Pharma | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Closter Pharma | ||||||||
| Verification Date | August 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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