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A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
Phase 2
Waitlist Available
Research Sponsored by Zhejiang Genfleet Therapeutics Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Summary
This trial will explore the safety & efficacy of GFH312, a potential new therapy for patients with Peripheral Artery Disease & other atherosclerotic diseases.
Eligible Conditions
- Intermittent Claudication
- Peripheral Arterial Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute change from baseline in maximum walking distance (MWD) at Week 12 assessed by a 6-minute walking test (6-MWT)
Incidence and severity of adverse events (AEs), SAEs
Secondary study objectives
Pain
Trial Design
4Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
Participant will receive placebo once daily approximately at same time each day for 12 weeks.
Group II: GFH312 80mgExperimental Treatment1 Intervention
Participant will receive GFH312 80mg once daily approximately at same time each day for 12 weeks.
Group III: GFH312 40mgExperimental Treatment1 Intervention
Participant will receive GFH312 40mg once daily approximately at same time each day for 12 weeks.
Group IV: GFH312 120mgExperimental Treatment1 Intervention
Participant will receive GFH312 120mg once daily approximately at same time each day for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GFH312
2021
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Zhejiang Genfleet Therapeutics Co., Ltd.Lead Sponsor
10 Previous Clinical Trials
904 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a heart attack or chest pain within the last 6 months.You had a stroke in the past 3 months.You have participated in another clinical study or are currently taking experimental medication within the past 4 weeks, or until the effects of the medication have worn off.You have certain conditions related to peripheral artery disease (PAD).You have severe blockages in the arteries of your lower limbs that cause painful ulcers, rest pain or gangrene.You have certain heart or metabolism conditions or diseases.You have experienced serious irregular heartbeats in the past 6 months, as determined by the investigator.You have an enlarged aortic aneurysm that is bigger than 5 centimeters in size.You have an electronic device in your heart called a pacemaker.You have a history of multiple significant allergies to medications that have recurred.You have PAD and can walk, but you don't have any other medical condition that makes it difficult to walk (such as a bone or muscle problem, breathing problem, or nerve issue).You have a condition where the arteries become inflamed, except for atherosclerosis or thromboangiitis obliterans.You have a long-term health condition from the list below:You have a mental disorder or dementia that could make it difficult for you to follow the study protocol, even with medication or therapy.You have been diagnosed with peripheral artery disease (PAD) and intermittent claudication (IC) for at least 6 months before screening, and your disease is at stage II according to the Fontaine classification.
Research Study Groups:
This trial has the following groups:- Group 1: GFH312 40mg
- Group 2: GFH312 80mg
- Group 3: GFH312 120mg
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.