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GFH312 40mg for Intermittent Claudication
Study Summary
This trial will explore the safety & efficacy of GFH312, a potential new therapy for patients with Peripheral Artery Disease & other atherosclerotic diseases.
- Intermittent Claudication
- Peripheral Arterial Disease
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: GFH312 40mg
- Group 2: GFH312 80mg
- Group 3: GFH312 120mg
- Group 4: Placebo
- 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.
Frequently Asked Questions
Am I eligible to enrol in this research program?
"This clinical trial is recruiting a hundred individuals aged 40 to 80 with intermittent claudication. Notably, candidates must have had PAD and IC for at least half a year prior to screening as well as having their disease classified according to the Fontaine classification system stage II."
Are persons below the age of 65 able to partake in this clinical trial?
"Per the eligibility criteria, individuals aged 40 to 80 are qualified for this trial. Moreover, there are 10 studies that accept minors and 221 trials specifically tailored to senior citizens."
What adverse effects should be expected from ingesting GFH312 120mg?
"Our team has cautiously assigned a score of 2 to GFH312 120mg due to the lack of evidence-based data that supports its efficacy. However, there is some safety information supporting this dosage form."
What is the aggregate figure of enrollees for this research project?
"Affirmative. Data on clinicaltrials.gov proves that this medical trial is currently enrolling members, which was first posted December 1st 2022 and revised April 13th 2023. The investigation necessitates the recruitment of 100 patients from one site."
Does this clinical experiment have any open spots for participants?
"Affirmative, according to clinicaltrials.gov this study is currently recruiting participants for their trial as of April 13th 2023 having been first posted on December 1st 2022. The research aims to secure 100 test subjects at one medical location."
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