EUCTR2010-019009-40-CZ进行中（未招募）不适用
A PHASE 2A RANDOMIZED DOUBLE-BLINDED, PLACEBO AND ACTIVE CONTROLLED TWO COHORT TWO DOSES CROSS-OVER MULTI-CENTER CLINICAL STUDY TO ASSESS EFFICACY OF A ONCE DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) FOR THE TREATMENT OF VASOSPASM IN PRIMARY AND SECONDARY RAYNAUD’S PHENOMENO
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK0 个研究点目标入组 208 人开始时间: 2010年7月22日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
- •1. Male or female subjects between 18 and 65 years of age.
- •2. Active Raynaud's Phenomenon defined as episodic digital pallor followed by cyanosis and/or erythema in response to cold or emotion.
- •3. SRP subjects must also have a diagnosis of scleroderma defined by the American College of Rheumatology (ACR) criteria or by the presence of at least 3 of the 5 features of the CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal dysmotility, sclerodactyly, telangiectasias).
- •4. Subjects must have at least seven RP attacks per week on five or more days per week. This may be self-reported at the Screen Visit.
- •5. Stable disease and medication requirements over the previous 2 months. Calcium channel blockers and NSAIDs are permitted, but subjects will not be able to change the dose or begin calcium channel blockers/NSAIDs upon enrollment in the study. ACE-I are permitted if required for hypertension and/or scleroderma related renal disease.
- •6. Unchanged immunosuppressive therapy 3 months before treatment with PF-00489791.
- •7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •8. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1. Subjects who currently smoke. Ex-smokers are defined as having not smoked for at least 3 months.
- •2. Subjects using smoking cessation treatments (eg nicotine patches).
- •3. Subjects with a history of stroke, myocardial infarction or life threatening arrhythmia within the last six months.
- •4. Subjects with uncontrolled hypertension.(SBP>150 mm Hg, DBP >100 mmHg).
- •5. Subjects with uncontrolled diabetes mellitus with HbA1c>7%.
- •6. Subjects who had severe cardiac failure (New York Heart Association IV classification) or unstable angina within the last six months.
- •7. Subjects with hemodynamic instability or systolic arterial pressure less than 90 mmHg and/or symptomatic orthostatic hypotension.
- •8. Subjects with impairment of hepatic function (ALT and/or AST >3 x Upper Limits of Normal (ULN) and/or bilirubin =2 mg/dL) at screening.
- •9. Subjects with impairment of renal function (serum creatinine >2.5 x ULN) at screening.
- •10. Subjects who have had surgical sympathectomy performed in the previous 12 months.
- •11. Subjects with a history of upper extremity deep vein thrombosis or lymphedema within the previous 3 months.
- •12. Subjects with known hereditary degenerative retinal disorders (such as retinitis pigmentosa) or history of non-arteritic anterior ischemic optic neuropathy (NAION) or untreated proliferative diabetic retinopathy.
- •13. Subjects with previous intolerance or allergy to PDE5 inhibitors or a history of multiple clinically significant allergies.
- •14. Subjects who currently use phosphodiesterase inhibitors or with previous chronic use of phosphodiesterase inhibitors for any reason (eg, sildenafil, tadalafil, vardenafil).
- •15. Subjects who are unable to withdraw from vasodilators or any of the following
- •therapies for 14 days before commencement of study:
- •Potent cytochrome P450 3A4 inhibitors eg, itraconazole, erythromycin,
- •ketoconazole, protease inhibitors;
- •Nitrates or nitric oxide donors;
- •Ritonavir or Nicorandil;
- •Theophylline; pentoxifylline
- •Alpha blockers;
- •Iloprost;
- •Bosentan;
- •ACE-I or angiotensin receptor inhibitor;
- •Corticosteroids (unless on a stable dose of less than or equal to 10 mg of prednisone a day or equivalent for at least 3 months);
- •Aspirin (except 81 mg per day or low-dose per local regulations);
- •Dipyridamole;
- •Other antiplatelet agents (eg, Ticlopidine, Clopidogrel).
- •16. Subjects with active alcoholism and/or drug abuse within the past 5 years.
- •17. Subjects with a history of HIV, Hepatitis B or C infection.
- •18. Subjects who are pregnant or breast feeding or considering pregnancy in next 4 months. Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication and through 14 days following the last dose of study drug.
- •19. Subjects with prior participation in a clinical trial for an investigational drug and/or agent within 30 days of entry.
- •20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
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