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)
Recruitment status was Recruiting
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)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429233
|Contact: Sandra M Casiano, M.D.||firstname.lastname@example.org|
|Contact: Harold Mejiaemail@example.com|
|Country Club Bogota||Recruiting|
|Principal Investigator: Andres Romero, MD|