NCT05400395招募中4 期
A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients With Intermittent Claudication
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Walking Distance in comparison with the findings from at baseline
研究概览
简要总结
This is a Phase 4, randomized clinical trial to evaluate whether GNX80 vs. placebo, prescribed for 6 months to patients with Intermittent Claudication(IC) would lead to an improvement in the walking distance.
详细描述
A Prospective, Randomized, Placebo-controlled, Double-blinded, Multi-center, Phase IV, Exploratory Clinical Trial to Demonstrate the Effect of Improving the Walking Distance by GNX80 in Patients with Intermittent Claudication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of at least 20 years
- •Angiographically confirmed peripheral arterial disease
- •Intermittent claudication for more than 6 months
排除标准
- •Severe impairment of heart, liver, or kidney function
- •Limitation of walking ability due to respiratory insufficiency or to an orthopaedic condition
- •Poorly controlled diabetes mellitus
- •Positive pregnancy test
- •Planned surgical or endovascular procedures other than for the treatment of IC
研究组 & 干预措施
GNX
Experimental
GNX / 80mg / BID / PO
干预措施: GNX80 (Drug)
Placebo
Placebo Comparator
Placebo / BID / PO
干预措施: Placebo (Drug)
结局指标
主要结局
Walking Distance in comparison with the findings from at baseline
时间窗: 24 weeks
walking distance evaluated by a constant treadmill test
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary AngioedemaHereditary AngioedemaNCT04898309AO GENERIUM
已完成
3 期
Study of NGX-4010 for the Treatment of Postherpetic NeuralgiaPeripheral Nervous System DiseasesPainNeuralgiaShinglesHerpes ZosterNCT00115310NeurogesX400
已完成
4 期
Guanfacine Extended Release for the Reduction of Aggression and Self-injurious Behavior Associated With Prader-Willi SyndromePrader-Willi SyndromeAggressionSelf-Injurious BehaviorPathologic ProcessesBehavioral SymptomsNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesChromosome DisordersGenetic Diseases, InbornNutrition DisordersAntihypertensive AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPhysiological Effects of DrugsSkin-PickingOvernutritionObesityIntellectual DisabilityNCT05657860Maimonides Medical Center15
已完成
2 期
NGX-4010 for the Treatment of Postherpetic NeuralgiaNeuralgiaPainPeripheral Nervous System DiseasesShinglesHerpes ZosterNCT00061776NeurogesX300
已完成
3 期
Study of NGX-4010 for the Treatment of Painful HIV-Associated NeuropathyPeripheral Nervous System DiseasesPainHIV InfectionsNCT00064623NeurogesX300