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Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
West Los Angeles VA Healthcare, Pulmonary Hypertension Program
Los Angeles, California, 90073 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Arterial Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated
according to national license

- Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge
pressure of randomization.

- Subjects whose baseline 6 Minute Walk Test distance is >100m and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- PAH secondary to any aetiology including congenital heart disease other than those
specified in the inclusion criteria

- Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related
dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.

NCT00323297
Pfizer
Completed
Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension

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Similar Trials

Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension
A Multinational, Multicentre, Randomized, Double-blind Study To Assess The Efficacy And Safety Of Oral Sildenafil 20mg Tid Or Placebo When Added To Bosentan In The Treatment Of Subjects, Aged 18 Years And Above, With Pulmonary Arterial Hypertension (Pah)
To assess the efficacy and safety of sildenafil when added to patients with PAH who are taking bosentan as all or part of their background therapy.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Bosentan
    Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
  • Other: Placebo
    Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
  • Drug: Bosentan
    Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
  • Drug: Sildenafil Citrate
    Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase
  • Placebo Comparator: placebo
    Interventions:
    • Drug: Bosentan
    • Other: Placebo
  • Experimental: Active
    Interventions:
    • Drug: Bosentan
    • Drug: Sildenafil Citrate
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects aged 18 and over above with PAH and for which bosentan therapy is indicated according to national license
  • Subjects with a mean pulmonary artery pressure of >25mmHg and a pulmonary artery wedge pressure of <15mmHg at rest via right heart catheterization within 3 years prior to randomization.
  • Subjects whose baseline 6 Minute Walk Test distance is >100m and < 450m.

Exclusion Criteria:

  • PAH secondary to any aetiology including congenital heart disease other than those specified in the inclusion criteria
  • Subjects whose 6 Minute Walk Test may be limited by conditions other than PAH related dyspnoea or fatigue eg. claudication from vascular insufficiency or arthritis.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Czech Republic,   France,   Germany,   Greece,   Israel,   Italy,   Taiwan,   United Kingdom,   United States
Belgium
 
NCT00323297
A1481243
2006-001464-23 ( EudraCT Number )
PATHWAYS ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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