A Research Study To Assess The Effectiveness And Safety Of Different Doses Of Oral PF-00489791 In The Treatment Of Adult Patients With Pulmonary Arterial Hypertension.

Phase 2

• Conditions: Health Condition 1: null- Hypertension, Pulmonary

• Registration Number: CTRI/2009/091/000279
• Lead Sponsor: Pfizer Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Other (Terminated)
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

a. Ages Eligible for Study: 18 Years and older,

b. Genders Eligible for Study: Both,

c. Accepts Healthy Volunteers: No,

1.Idiopathic or familial pulmonary arterial hypertension (PAH)

2.Mean PAP at least 25 mm Hg, PCWP lessthan 15 mm Hg at rest

3.For females of child-bearing potential negative pregnancy test at screening and use of contraception during the study and 4 weeks after its completion

4.Signed and dated informed consent

5.Willingness to comply with the study plan and procedures

There is no upper age limit for inclusion criteria in this trial

Exclusion Criteria

1.pulmonary arterial hypertension (PAH)other than idiopathic or familial

2.For females, pregnancy or lactation

3.Use of specific PAH treatments, potent CYP3A4 inhibitors, protease inhibitors, alpha blockers or arginine 30 days prior tio randomization and during the study

4.Change of dose or class of standard background PAH therapy, i.e. oxygen, calcium channel blockerts, digoxin, diuretics 30 days prior tio randomization and during the study

5.Large shift in altitude (defined as greaterthan 5000 feet or 1524 meters) during 90 days prior to baseline visit and/or during the study visit

6.Subjects with intracardiac shunts and/or serious heart, lung or other health conditions

7.HIV positive subjects

8.Subjects participating in another clinical trial with an investigational drug or device

9.Subjects with degenerative retinal disorders, history of non-arteritic anterior ischemic optic neuropathy or untreated proliferative diabetic retinopathy

10.Allergies and previous intolerance of PDE5 inhibitors

11.Alcohol or drug abuse

12.Blood donation during the study, or 1 month before or after the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified