Real-life Experience of the Use of Isomers as METPURE XL (S (-) Metoprolol Succinate) for Evaluation of Efficacy, Safety and Tolerability in the Management of Cardiovascular Disease in Colombian Patients (XPERT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Closter Pharma.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Closter Pharma
ClinicalTrials.gov Identifier:
NCT01426594
First received: August 29, 2011
Last updated: August 30, 2011
Last verified: August 2011
  Purpose

This is a Phase 4, observational, open study in patients who their doctor has prescribe METPURE XL (S (-)metoprolol succinate)by clinical practice. 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.


Condition
Hypertension
Coronary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Closter Pharma:

Primary Outcome Measures:
  • Effect of therapy in the management of cardiovascular diseases [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The objective is to mesure the effect of Metpure XL in cadiovascular diseases as hypertension, post MI and coronary disease


Secondary Outcome Measures:
  • Evaluate and compare the rate of compliance with treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Evaluate the compliance with METPURE XL, to be able to identify possible reasons for noncompliance or quitting the treatment

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    To assess the safety pattern in Colombian subjects using s(-)metoprolol succinate


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

Criteria

Inclusion Criteria:

  • Patients who were prescibed with s(-)metoprolol succinate(25mg, 50mg), depending on their clinical condition and use locally approved will be eligible to participate in this study
  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: NCT01426594

Contacts
Contact: Sandra M Casiano, MD 57-3174049763 scasiano@closterpharma.com
Contact: Harold Mejia 57-2264757 hmejia@closterpharma.com

Locations
Colombia
Country Club de 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: NCT01426594     History of Changes
Other Study ID Numbers: COL-CARDIO-NIS002
Study First Received: August 29, 2011
Last Updated: August 30, 2011
Health Authority: Colombia: INVIMA

Keywords provided by Closter Pharma:
Observational
Colombia
Metpure XL

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Disease
Coronary Artery Disease
Hypertension
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Metoprolol succinate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 25, 2014