Real Life Experience of the Use of Isomers as ALENCAL (Levamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients
XPRES
1 other identifier
observational
2,000
1 country
1
Brief Summary
This is a Phase 4, observational, open study in patients whom their doctor for clinical practice prescribes levamlodipine. 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, or clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 29, 2011
CompletedFirst Posted
Study publicly available on registry
September 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 7, 2011
September 1, 2011
4 months
August 29, 2011
September 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of therapy in the management of hypertension and other cardiovascular diseases
The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy.
8 weeks
Secondary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
8 weeks
Eligibility Criteria
Primary care adults in Colombia
You may qualify if:
- Patients whose primary physician based on their clinical condition and locally approved use will be eligible to participate in this study, and have been prescribe with Levamlodipine.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Closter Pharmalead
Study Sites (1)
Country Club Bogota
Bogotá, Colombia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2011
First Posted
September 7, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2011
Study Completion
March 1, 2012
Last Updated
September 7, 2011
Record last verified: 2011-09