Assess the Efficacy and Safety of Sildenafil When Added to Bosentan in the Treatment of Pulmonary Arterial Hypertension. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00323297

Purpose

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.

Condition	Intervention	Phase
Pulmonary Arterial Hypertension	Drug: Bosentan Drug: Sildenafil Citrate	Phase IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Sildenafil citrate Sildenafil Citric acid Sodium Citrate Bosentan

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	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).

Further study details as provided by Pfizer:

Primary Outcome Measures:

To assess the effect on exercise capacity (as measured by the 6 Minute Walk Test) after 12 weeks [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the safety and tolerability of sildenafil (20mg TID) or placebo, when added to subjects with PAH who are currently treated with bosentan, after 12 weeks of treatment. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
To assess the safety and tolerability of the open label treatment of sildenafil (20mg TID) and bosentan therapy in subjects with PAH after 12 months of treatment. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To assess the effect on other clinical outcome measures (clinical worsening, Borg dyspnoea score and PAH functional class) after 12 weeks of treatment of sildenafil (20mg TID) or placebo when added to bosentan therapy in subjects with PAH. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
To determine the population pharmacokinetic parameters of sildenafil and bosentan and to investigate potential pharmacokinetic interactions between the two compounds in the target patient population. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
To investigate the Pharmacokinetic/Pharmacodynamic (PK/PD) relationship between sildenafil and bosentan exposure on the 6-Minute Walk Test. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	106
Study Start Date:	September 2006
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator	Drug: Bosentan Bosentan + Placebo for 12 weeks of the study (double blind), then 12 months open label phase (bosentan + sildenafil)
Active: Experimental	Drug: Sildenafil Citrate Bosentan + Sildenafil for 12 weeks of the study (double blind), then 12 months open label phase

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323297

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481243
Study First Received:	May 5, 2006
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00323297
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Idiopathic pulmonary hypertension
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Citric Acid

Vascular Diseases
Sildenafil
Bosentan
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009