Open Label Study of Sildenafil in Patients With Pulmonary Arterial Hypertension

NCT ID: NCT00454207

Last Updated: 2021-02-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2009-02-28

Brief Summary

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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)

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sildenafil citrate (UK-92,480)

sildenafil citrate 20 mg TID

Group Type EXPERIMENTAL

sildenafil citrate (UK-92,480)

Intervention Type DRUG

sildenafil citrate (UK-92,480)

Interventions

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sildenafil citrate (UK-92,480)

sildenafil citrate (UK-92,480)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Chiba, Chiba, Japan

Site Status

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Site Status

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Site Status

Pfizer Investigational Site

Okayama, Okayama-ken, Japan

Site Status

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Tokyo, , Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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JapicCTI-070381

Identifier Type: -

Identifier Source: secondary_id

A1481252

Identifier Type: -

Identifier Source: org_study_id

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