HypertensionXPRESNCT01429233
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
An observational study of Hypertension, run by Closter Pharma at 1 site in Colombia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 2,000 participants
- Where
- 1 siteColombia
- Study dates
- Aug 2011to Mar 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care adults in Colombia
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Country Club Bogota
Bogotá
Andres Romero, MD
About this study
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
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.
- Conditions
- Hypertension
- Keywords
- Observational, Colombia
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of therapy in the management of hypertension and other cardiovascular diseases
The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy.
Measured: 8 weeks
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Closter Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429233
- Sponsor's protocol ID
- COL-CARDIO-NIS001
- Acronym
- XPRES
- Status last verified
- Sep 2011
- First submitted
- 29 Aug 2011
- Last updated
- 7 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01429233
- Acronym / sponsor ID
- XPRES / COL-CARDIO-NIS001
- Conditions
- Hypertension
- Keywords
- Observational, Colombia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Closter PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care adults in Colombia
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effect of therapy in the management of hypertension and other cardiovascular diseases
Time frame: 8 weeks
The change from Baseline in Blood Pressure at 8 weeks will be measure to evaluate th efficacy of the therapy.
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Closter Pharma at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra M Casiano, M.D. (57-3174049763, scasiano@closterpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of therapy in the management of hypertension and other cardiovascular diseases (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2011.