Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

NCT00454207 | Completed Phase 3 Results

• 2 other identifiers: A1481252JapicCTI-070381
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

Brief Summary

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)

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Arterial Hypertension, PAH

Outcome Measures

Primary Outcomes (4)

• Change in the 6-minute Walk Distance From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Change：6-minute walk distance at Week 12 minus 6-minute walk distance at baseline. The 6-minute walk distance:total distance walked during the 6-minute walk test.

  Baseline, Week 12

• Change in the Mean Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Change:Mean pulmonary arterial pressure at Week 12 minus mean pulmonary arterial pressure at baseline.

  Baseline, Week 12

• Change in the Pulmonary Vascular Resistance From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Change：Pulmonary vascular resistance at Week 12 minus pulmonary vascular resistance at baseline

  Baseline, Week 12

• Change in the Cardiac Output From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Change：Cardiac output at Week 12 minus cardiac output at baseline

  Baseline, week 12

Secondary Outcomes (30)

• Change in the 6-minute Walk Distance From Baseline at Week 8 in Participants Who Entered the Study From Part I

  Baseline, Week 8

• Change in the Systolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Baseline, Week 12

• Change in the Diastolic Pulmonary Arterial Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Baseline, Week 12

• Change in the Systolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Baseline, Week 12

• Change in the Diastolic Systemic Blood Pressure From Baseline at Week 12 in Participants Who Entered the Study From Part I

  Baseline, Week 12

Study Arms (1)

sildenafil citrate (UK-92,480)

EXPERIMENTAL

sildenafil citrate 20 mg TID

Drug: sildenafil citrate (UK-92,480)

Interventions

sildenafil citrate (UK-92,480) DRUG

sildenafil citrate (UK-92,480)

sildenafil citrate (UK-92,480)

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (8)

Pfizer Investigational Site

Chiba, Chiba, Japan

Location

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Location

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Location

Pfizer Investigational Site

Okayama, Okayama-ken, Japan

Location

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Tokyo, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 30, 2007
• Study Start: April 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 21, 2021
• Results First Posted: September 9, 2010

Record last verified: 2021-01

Locations

JP (8)