EUCTR2016-000377-20-HU进行中（未招募）1 期
A Phase II, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multi-Center Study to Explore the Efficacy, Safety andTolerability of VK5211 in Subjects with Acute Hip Fracture
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Each subject must meet the following criteria to be eligible for the study (subjects may be rescreened for failure of inclusion/exclusion criteria after consultation with medical monitor):
- •1. Males or females =65 years old who experienced a hip fracture (occurring 3-11 weeks prior) with no residual surgical issues will be eligible for participation.
- •2. Subjects must be willing and able to sign informed consent.
- •3. Blood pressure within the following parameters: systolic blood pressure (SBP) <180 mmHg and diastolic blood pressure (DBP) < 100 mmHg) with a heart rate of 45 to 90 bpm measured at Screening after resting for 5 minutes in the seated position.
- •4. MMSE score = 20.
- •5. Ability to walk 4 meters at Screening with or without a cane or walker with a gait speed of = 0.8 m/s.
- •6. Suitable for participation in the study in the opinion of the Investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Subjects who meet any of the following criteria must be excluded from the study:
- •1. Clinically significant new illness in the 1 month prior to Screening. (The qualifying hip fracture does not count as a significant illness).
- •2. Cognitive impairment as indicated by a score of < 20 on the MMSE performed at Screening or as determined by Investigator judgment if 20 or higher.
- •3. Pathological fracture (e.g. fracture due to Paget’s disease of bone, malignancy, etc.). Fracture due to postmenopausal osteoporosis is not considered pathological for this trial.
- •4. Glycosylated hemoglobin (HbA1c) > 9.5 % at Screening.
- •5. Presence of hardware in the contralateral hip.
- •6. Previous participation in any clinical study with an investigational drug, biologic, or device within 4 weeks prior to Screening.
- •7. Previous participation in a VK5211 or LGD-4033 study.
- •8. Use of antibody-based therapy for bone disease within 6 months prior to Screening. Subjects taking antibody-based therapy may be weaned off and re-screened on a case-bycase basis pending evaluation by the Sponsor.
- •9. Use of the following medications within 30 days prior to Screening or during the study:
- •Hormone replacement therapy with estrogen agonists or SERMs (vaginal estrogens are permitted).
- •Teriperatide (Forteo) is excluded;[supplemental Vitamin D3 and/or Calcium is permitted].
- •Initiation of ANY new bone active therapy after Screening for duration of the study and follow up period (examples include IV and oral bisphosphonates, Denosumab, Teriperatide, etc.)
- •10. History of severe allergies (i.e., anyone with a known history of anaphylaxis to medication[s] or allergens).
- •11. Subject who has donated any blood, or had significant blood loss not associated with the qualifying hip fracture within 56 days prior to dosing.
- •12. Subject who has donated plasma within 7 days prior to dosing.
- •13. History of regular smoking or tobacco use within 3 months prior to Screening.
- •14. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that may prevent compliance with the protocol.
- •15. Not suitable to participate in the study in the opinion of the Investigator on the basis of clinically significant laboratory values.
- •16. ECG will be performed at Screening. Subjects with QTcF interval >450 msec (or >500 msec in the presence of a bundle branch block or paced ventricular rhythm) or any other exclusionary cardiac conditions noted previously on the locally read ECG are excluded from study participation. Other abnormal findings on the ECG should be carefully
- •considered and any subject excluded who, in the judgment of the PI, may not safely complete treatment in this study.
- •17. History of active or uncontrolled heart failure or hypertension within 3 months of Screening.
- •18. Symptoms of acute or unstable coronary artery disease within 6 months of Screening.
- •19. History of cerebrovascular disease within 1 year of Screening.
- •20. History of epilepsy or any other seizure disorder within 1 year of Screening.
- •21. History of unexplained or untreated syncope in the past 12 months.
- •22. History of organ transplantation.
- •23. Positive history of human immunodeficiency virus, or acute/active hepatitis B, or hepatitis C.
- •24. Malignancy within 5 years of Screening (with the exception of previously treated basal cell carcinoma and squamous cell skin carcinoma in-situ).
- •25. History (within 2 years prior to Screening) of alcoho
研究者
相似试验
进行中（未招募）
不适用
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura - Combination DosingMigraineEUCTR2008-004095-43-DEMerck & Co., Inc.628
进行中（未招募）
不适用
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura - Combination DosingMedDRA version: 9.1Level: LLTClassification code 10027599Term: MigraineMigraineEUCTR2008-004095-43-FIMSD Finland Oy628
进行中（未招募）
1 期
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without AuraMigraineEUCTR2008-004095-43-FRaboratoires Merck Sharp & Dohme-Chibret640
进行中（未招募）
不适用
A Phase IIa Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled, Clinical Trial to Study the Efficacy and Safety of MK-0974 Co-administered with Ibuprofen or Acetaminophen in Patients with Migraine With or Without Aura - Combination DosingMigraineEUCTR2008-004095-43-HUMerck & Co., Inc.628
进行中（未招募）
不适用
A Phase IIa Randomized, Double-Blind, Parallel-Groups, Placebo-Controlled ClinicalTrial to Study the Efficacy and Safety of MK-0724 Intravenous Infusion on theAmelioration of Neurological Damage and Recovery from Middle Cerebral ArteryIschemic StrokeEUCTR2008-002079-28-ATMerck Sharp & Dohme GmbH150