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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Closter Pharma.
Recruitment status was  Recruiting
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 21, 2014