CTRI/2009/091/000279Other2 期
A Phase 2a, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study Investigating The Dose-Response Of PF-00489791 On Acute Hemodynamics In Subjects With Idiopathic And Familial Pulmonary ARTERIAL Hypertension. - Not applicable
试验速览
- 阶段
- 2 期
- 状态
- Other
- 入组人数
- 72
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
排除标准
- •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
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