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 study is currently recruiting participants.
Verified September 2011 by Closter Pharma
Sponsor:
Closter Pharma
Information provided by (Responsible Party):
Closter Pharma
ClinicalTrials.gov Identifier:
NCT01429233
First received: August 29, 2011
Last updated: September 6, 2011
Last verified: September 2011
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Purpose
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.
| Condition |
|---|
|
Hypertension |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by Closter Pharma:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| 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 in Colombia
Criteria
Inclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01429233
Contacts
| Contact: Sandra M Casiano, M.D. | 57-3174049763 | scasiano@closterpharma.com |
| Contact: Harold Mejia | 57-2264757 | hmejia@closterpharma.com |
Locations
| Colombia | |
| Country Club 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: | NCT01429233 History of Changes |
| Other Study ID Numbers: | COL-CARDIO-NIS001 |
| Study First Received: | August 29, 2011 |
| Last Updated: | September 6, 2011 |
| Health Authority: | Colombia: INVIMA |
Keywords provided by Closter Pharma:
|
Observational Colombia |
Additional relevant MeSH terms:
|
Cardiovascular Diseases Hypertension Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013