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Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01091012
First Posted: March 23, 2010
Last Update Posted: September 11, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
March 2, 2010
March 23, 2010
September 11, 2012
September 2011
December 2012   (Final data collection date for primary outcome measure)
Effectiveness [ Time Frame: one day per patient ]
The main efficacy parameter is the effect on pulmonary vascular vasodilation quantified as decreased Pulmonary Vascular Resistance.
Same as current
Complete list of historical versions of study NCT01091012 on ClinicalTrials.gov Archive Site
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Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension
Study About Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension, at Last Moderate and Secondary at Valve Disease(Corrected With a Normally Functioning Prosthesis).
The main objective is to validate the safety and efficacy of intravenous and oral sildenafil in the acute vasodilator test in patients with persistence of, at least, moderate pulmonary hypertension after valvular surgery successfully, with a correct left ventricular function and no valvular disease hemodynamically significant.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Pulmonary Hypertension
Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
Other Name: REVATIO oral vs REVATIO intravenous
  • Sildenafil 20mg oral
    Intervention: Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
  • Sildenafil 10mg intravenous
    Intervention: Drug: Sildenafil 20mg oral vs Sildenafil 10mg intravenous
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
February 2013
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients clinically stable, at least 1 year after the completion of successful valve surgery, with persistent pulmonary artery systolic pressure> 50 mmHg,
  • normal left ventricular function and no significant valvular disease in 2 separate Doppler ultrasound studies at least 1 month.

Exclusion Criteria:

  • Patients with other cardiac and noncardiac diseases will be excluded.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01091012
DOM-SIL-2009
2009-012005-19 ( EudraCT Number )
No
Not Provided
Not Provided
Hospital Universitari Vall d'Hebron Research Institute
Hospital Universitari Vall d'Hebron Research Institute
Not Provided
Principal Investigator: Enric Domingo, Promotor Vall Hebron Hospital
Hospital Universitari Vall d'Hebron Research Institute
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP