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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00483626 |
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Date of registration:
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06/06/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Hemodynamic Response After Six Months of Sildenafil
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Scientific title:
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Hemodynamic Evaluation of Patients With Pulmonary Arterial Hypertension. Response to Sildenafil Treatment |
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Date of first enrolment:
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August 2003 |
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Target sample size:
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27 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00483626 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Chile
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Contacts
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Name:
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Monica M Zagolin, MD |
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Address:
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Telephone:
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056-2-3403505 |
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Email:
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monizagolin@hotmail.com |
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Affiliation:
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Name:
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Monica M Zagolin, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Thorax |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients older than 15 years old with Pulmonary arterial hypertension according with
WHO hemodynamic definition,
- Who signed informed consent,
- Able to swallow tablets and follow instructions.
Exclusion Criteria:
- Patients with pulmonary hypertension with other categories than pulmonary arterial
hypertension (associated to COPD, lund diseases, sleep apnea, thromboembolic disease,
hight altitude), patients asymptomatic, patients who were responders to adenosine
during hemodynamic test, patients treated with specific treatments for pulmonary
arterial hypertension before started the study such as sildenafil, prostanoids,
endothelin receptors blockers.
Age minimum:
16 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Arterial Hypertension
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Intervention(s)
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Drug: oral sildenafil
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Primary Outcome(s)
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Arterial pulmonary resistance index
[Time Frame: 6 months]
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Secondary Outcome(s)
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Mean pulmonary arterial pressure, Cardiac index, pulmonary saturation, walked distance, functional class.
[Time Frame: 6 months]
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Secondary ID(s)
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Thorax-001-2003
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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