You are here

Our science / Clinical Trials / Find a Trial / NCT00430716

To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

Back to Search Print Save as PDF Bookmark Trial

NCT00430716

Last updated on May 11, 2018
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85013 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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 with PAH (i.e. IPAH or secondary to connective tissue disease or with
surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute
walk test distance is >/= 100 m and = 450 m.

- Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery
wedge pressure of = 15 mmHg at rest via right heart catheterization performed within
12 weeks prior to randomization.

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

- Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH
related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or
significant arthritis.

- Subjects who are currently receiving any forms of chronic treatment for PAH such as
prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric
oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors
such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers.
Subjects previously receiving any of these drugs must have stopped use for a period of
at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3
months).

NCT00430716
Pfizer
Terminated
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
Advanced Search

Similar Trials

Familial Persistent Pulmonary Hypertension
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
NCT01720524
All Genders
0+
Years
Multiple Sites
Hypertension
A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents
NCT00389519
All Genders
6+
Years
Multiple Sites
Resistant Hypertension
A Study Of Different Doses Of TBC3711 In Patients With Uncontrolled High Blood Pressure Already Taking Medications For High Blood Pressure.
NCT00272961
All Genders
18+
Years
Multiple Sites
Open-Angle Glaucoma, Ocular Hypertension
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma
NCT00159653
All Genders
18+
Years
Multiple Sites
To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
A Multinational, Multicentre, Randomized, Parallel Group, Double-Blind Study To Assess The Efficacy and Safety Of 1 mg, 5 mg and 20 mg TID of Oral Sildenafil in the Treatment of Subjects Aged 18 Years and Over With Pulmonary Arterial Hypertension (PAH)
To demonstrate a dose response for 1 mg, 5 mg and 20 mg TID oral sildenafil for the treatment of subjects with PAH.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Pulmonary Arterial Hypertension
  • Drug: Sildenafil citrate
    oral, 20 mg, tid
  • Drug: Sildenafil citrate
    oral 1 mg, tid
  • Drug: Sildenafil citrate
    oral 5 mg, tid
  • Drug: Sildenafil citrate
    oral 20 mg, tid
  • Experimental: Sildenafil High dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil Low dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil medium dose
    Intervention: Drug: Sildenafil citrate
  • Experimental: Sildenafil - Open label Phase
    Open label extension from week 12 to week 24.
    Intervention: 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.
 
Terminated
130
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects with PAH (i.e. IPAH or secondary to connective tissue disease or with surgical repair of ASD, VSD, PDA, aorto-pulmonary window) whose baseline six minute walk test distance is >/= 100 m and
  • Subjects with a mean pulmonary artery pressure of >/= 25 mmHg and a pulmonary artery wedge pressure of

Exclusion Criteria:

  • Subjects whose 6 Minute Walk Distance may be limited by conditions other than PAH related dyspnoea or fatigue, e.g. claudication from vascular insufficiency or significant arthritis.
  • Subjects who are currently receiving any forms of chronic treatment for PAH such as prostacyclin, PDE-5 inhibitors, endothelin-receptor antagonists, nitrates or nitric oxide donors (e.g. arginine supplement, nicorandil) in any form, protease inhibitors such as ritonavir and saquinavir, ketoconazole, itraconazole, and alpha blockers. Subjects previously receiving any of these drugs must have stopped use for a period of at least 1 month prior to screening, except in the case of bosentan or prostacyclin (3 months).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Bulgaria,   China,   Greece,   India,   Italy,   Latvia,   Malaysia,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   Thailand,   United Kingdom,   United States
Denmark,   Panama
 
NCT00430716
A1481244
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now