EUCTR2010-020376-37-CZ进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Adaptive, AscendingDose-Titration Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Invasive Hemodynamics of TRV120027 inPatients with Stable Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
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
- •1) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- •2) Male or female, age = 18 and = 65 years. Males must agree to use appropriate birth control measures including condoms for at least 1 week following participation in the study (Section 7.3). Females must be of non-childbearing potential as defined below.
- •a) Pre-menopausal females with documented (medical report verification) hysterectomy or bilateral oophrectomy, or
- •b) Post-menopausal females with at least 12 months of spontaneous amenorrhea; or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels = 40 IU/L or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
- •3) Diagnosis of congestive heart failure made at least 3 months prior to screening and confirmed with at least one elevated BNP (or NT-proBNP) concentration (greater than laboratory reference range) performed within 3 months of IMP administration (may be obtained during screening).
- •4) Ejection fraction = 35% as measured using any quantitative imaging modality (e.g. echocardiography, radionuclide imaging, MRI, CT) within 3 months prior to screening.
- •5) NYHA Class III or IV heart failure, and in the opinion of the investigator, right-heart catheterization is clinically indicated.
- •6) Systolic blood pressure at screening taken after at least 10 minutes at rest must be = 100 mmHg. Heart rate at screening taken after at least 10 minutes at rest must be < 90 bpm. The blood pressure and/or heart rate may be repeated if the Investigator believes that including the subject will not pose unacceptable risk to the subject or compromise interpretation of the tolerability or pharmacodynamic data.
- •7) Oxygen saturation = 94% on room air (= 92% for high altitude locations).
- •8) Weight = 125 kg at baseline.
- •9) For males, serum creatinine = 1.8 mg/dL (= 160 µmol/L); for females, serum creatinine = 1.5 mg/dL (133 µmol/L).
- •10) Clinical laboratory tests within the lab reference ranges or within clinically acceptable limits as determined by the Investigator.
- •11) Baseline mean PCWP = 20 mmHg with three consecutive measures where the highest and lowest values are within 4 mmHg of each other.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •Subjects will be excluded if any of the following apply:
- •1) Any significant disease or condition that would interfere with the interpretation of safety or efficacy in this study as determined by the Investigator based on medical history, physical examination or laboratory tests.
- •2) Presence of clinically significant anemia at screening.
- •3) Any other serious life threatening disease, for example uncontrolled or poorly controlled seizure disorder, poorly controlled diabetes mellitus, chronic obstructive pulmonary disease, that may impair the interpretation of safety or efficacy data from the study.
- •4) Contraindication to the placement of a PAC, or placement of PAC not feasible
- •5) Medications:
- •a) Has received an intravenous vasodilator (e.g. nitroglycerin, nitroprusside, nesiritide) within 24 hours of initiating IMP.
- •b) Has received any dose of an intravenous inotrope or chronotrope (e.g. milrinone, dobutamine) within 48 hours of initiating IMP.
- •c) Use of a phosphodiesterase type-5 (PDE5) inhibitor (e.g. sildenafil, vardenafil, tadalafil) within 1 week of initiating IMP.
- •d) Use of angiotensin receptor blocking drugs within 7 days of initiating IMP.
- •e) Use of any investigational medication within 30 days or 5 half-lives (whichever is longer) within 30 days prior to IMP administration.
- •6) Uncorrected and hemodynamically significant aortic or mitral stenosis, or aortic regurgitation.
- •7) Clinical signs or symptoms of cardiogenic shock.
- •8) Current signs or symptoms of acute myocardial ischemia.
- •9) Acute coronary syndrome (ACS) or coronary revascularization in the past 3 months.
- •10) Complex congenital heart disease.
- •11) Primary myocardial infiltrative disease (e.g. hypertrophic cardiomyopathy, amyloidosis, sarcoidosis, hemochromatosis).
- •12) Sustained or uncontrolled ventricular arrhythmia. Inclusion of patients with atrial fibrillation with a heart rate = 90 bpm is permitted.
- •13) Ventricular assist device or intra-aortic balloon pump in place.
- •14) Ultrafiltration at time of randomization.
- •15) Post-cardiac or renal transplant.
- •16) Major surgery within 8 weeks prior to IMP administration.
- •17) Stroke in the past 6 months.
- •18) Allergy or intolerance of angiotensin receptor blockers or ACE inhibitors.
- •19) Illicit drug use within 6 months of IMP initiation.
- •20) Pregnant or lactating.
研究者
相似试验
进行中（未招募）
1 期
A study to test the effectiveness and safety of test product BIIB092 compared to placebo in participants with progressive supranuclear palsy, arare and progressive condition that can cause problems with balance, movement, vision, speech and swallowingProgressive supranuclear palsyMedDRA version: 21.1Level: PTClassification code 10036813Term: Progressive supranuclear palsySystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-002554-21-ITBIOGEN IDEC RESEARCH LIMITED490
进行中（未招募）
1 期
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With AlirocumabMedDRA version: 19.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersAcute coronary syndromeEUCTR2011-005698-21-PLsanofi-aventis Recherche & Développement18,600
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging, Multicenter Study of the Efficacy of RWJ-333369 in the Prophylaxis of MigraineProphylaxis of migraine with or without aura, in patients with a diagnosis of at least 1-year duration.MedDRA version: 6.1Level: PTClassification code 10027607EUCTR2004-004162-33-ITJANSSEN-CILAG
进行中（未招募）
1 期
A study of Baricitinib in patients with LupusSystemic Lupus Erythematosus (SLE)MedDRA version: 21.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemicSystem Organ Class: 100000004859EUCTR2017-005026-37-HREli Lilly and Company825
已完成
3 期
This study is to evaluate the efficacy and safety of 2 different doses of canagliflozin compared with placebo in older patients (55 to 80 years of age) with type 2 diabetes mellitus (T2DM) with inadequate control on their current diabetes treatment regimen.CTRI/2010/091/002997Johnson Johnson Ltd720