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)
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Real Life Experience of the Use of Isomers as ALENCAL(Levoamlodipine) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients|
- Effect of therapy in the management of hypertension and other cardiovascular diseases [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]The number of Participants with Serious and Non- seriuous Adverse Events wil be mesure to evaluate the tolerability and safety profile in 8 weeks follow up.
|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)|
|Contact: Sandra M Casiano, M.D.||firstname.lastname@example.org|
|Contact: Harold Mejiaemail@example.com|
|Country Club Bogota||Recruiting|
|Principal Investigator: Andres Romero, MD|