Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension - Full Text View

Purpose

To assess the safety of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1 and 2) To assess the efficacy after 12 weeks of treatment of sildenafil 20 mg TID orally given to Japanese pulmonary arterial hypertension patients (Part 1)

Condition	Intervention	Phase
Pulmonary Hypertension	Drug: sildenafil citrate	Phase III

Genetics Home Reference related topics:

pulmonary arterial hypertension

MedlinePlus related topics:

High Blood Pressure Pulmonary Hypertension

ChemIDplus related topics:

Sildenafil citrate Sildenafil Citric acid Sodium Citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Phase 3, Multi-Center, Open-Label Study to Assess Safety and Efficacy of Sildenafil Citrate 20 mg TID in Subjects With Pulmonary Arterial Hypertension

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change from baseline at Week 12 in haemodynamics parameters: mean pulmonary arterial pressure (mPAP), pulmonary vascular resistance (PVR) and cardiac output (CO) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The incidence of all adverse events [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Change from baseline in the total distance walked during the 6-Minute Walk test at Week 12 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Abnormal laboratory changes [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
Vital signs changes [ Time Frame: End of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline at Week 12 in the additional haemodynamics parameters: PAP (systolic, diastolic), systemic blood pressure (systolic, diastolic, mean), PCWP, RAP, CI, heart rate, PVRI, SVR, SVRI, SvO2, SaO2, PaO2, PvO2 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change from baseline at Week 8 and 12 in the BORG dyspnoea score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Change from baseline at Week 4, 8 and 12 in the BNP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Pharmacokinetics: PK parameters of sildenafil and its metabolite, UK-103,320, at steady state following sildenafil administration; Tmax, Cmax and AUC0-t [ Time Frame: End of study ] [ Designated as safety issue: No ]
Change from baseline in the total distance walked during the 6-Minute Walk test at Week 8 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Change from baseline at Week 4, 8 and 12 in WHO function classification [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	April 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
sildenafil citrate: Experimental sildenafil citrate 20 mg TID	Drug: sildenafil citrate UK-92,480

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects aged 16 and over, and classified as having pulmonary arterial hypertension
Subjects who meet the following conditions on right heart catheterization at screening or baseline: mean pulmonary arterial pressure of ≥ 25mmHg and pulmonary capillary wedge pressure of ≤ 15mmHg at rest
Subjects whose baseline 6-Minute Walk test distance is >100 m and <450 m

Exclusion Criteria:

Significant Hepatic and/or renal disorder
Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic ischemic optic neuropathy (NAION)
Subjects who are currently receiving nitrates or nitric oxide donors in any form, ritonavir, ketoconazole and itraconazole

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454207

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


Japan
	Pfizer Investigational Site	Recruiting
	Tokyo, Japan

Japan, Chiba
	Pfizer Investigational Site	Recruiting
	Chiba-shi, Chiba, Japan

Japan, Ishikawa
	Pfizer Investigational Site	Recruiting
	Kanazawa, Ishikawa, Japan

Japan, Mie
	Pfizer Investigational Site	Recruiting
	Tsu-shi, Mie, Japan

Japan, Okayama
	Pfizer Investigational Site	Recruiting
	Okayama City, Okayama, Japan

Japan, Osaka
	Pfizer Investigational Site	Not yet recruiting
	Suita City, Osaka, Japan

Japan, Shizuoka
	Pfizer Investigational Site	Recruiting
	Hamamatsu-shi, Shizuoka, Japan

Japan, Tokyo
	Pfizer Investigational Site	Recruiting
	Shinjuku-ku, Tokyo, Japan
	Pfizer Investigational Site	Recruiting
	Bunkyo-ku, Tokyo, Japan

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A1481252, JapicCTI-070381
First Received:	March 28, 2007
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00454207
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Pfizer:

Pulmonary Arterial Hypertension, PAH

Study placed in the following topic categories:

Idiopathic pulmonary hypertension

Respiratory Tract Diseases

Hypertension, Pulmonary

Lung Diseases

Citric Acid

Vascular Diseases

Sildenafil

Hypertension

Additional relevant MeSH terms:

Vasodilator Agents

Phosphodiesterase Inhibitors

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Enzyme Inhibitors

Cardiovascular Diseases

Cardiovascular Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00454207