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ACE Inhibitor
Ramipril for Intermittent Claudication
Phase 4
Recruiting
Led By Iraklis I Pipinos, MD
Research Sponsored by University of Nebraska
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 6 months
Awards & highlights
Study Summary
This trialwill study whether Ramipril can improve walking performance and quality of life in patients with PAD-related claudication.
Who is the study for?
This trial is for individuals with Peripheral Artery Disease (PAD) who experience leg pain during walking due to claudication. They should have stable blood pressure, cholesterol, and diabetes management. Participants must not have severe kidney issues, a history of angioedema with ACE inhibitors, critical limb ischemia, or other conditions severely affecting their walking ability.Check my eligibility
What is being tested?
The study tests if Ramipril can improve walking performance and quality of life in PAD patients by reducing muscle damage and fibrosis compared to standard treatments like cilostazol and pentoxifylline. It's hypothesized that Ramipril may help by decreasing oxidative damage in muscles.See study design
What are the potential side effects?
Ramipril may cause side effects such as coughing, high potassium levels which can affect the heart rhythm, low blood pressure especially after the first dose, dizziness due to low blood pressure, headaches or tiredness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Absolute Claudication Distance
Secondary outcome measures
6-minute Walking Distance
Average Daily Steps Taken
Capillary density.
+20 moreSide effects data
From 2009 Phase 4 trial • 252 Patients • NCT003918469%
Cardiac Failure
4%
Myocardial Infarction
2%
Ventricular Tachycardia
2%
Anaemia
2%
Chronic Obstructive Pulmonary Disease
2%
Syncope
2%
Angina Pectoris
2%
Artial Fibrillation
2%
Dyspnoea
2%
Hyperkalaemia
2%
Pneumonia
1%
Cerebral Infarction
1%
Dyspepsia
1%
Duodenal Ulcer Haemorrhage
1%
Confusional State
1%
Polymyalgia Rheumatica
1%
Cerebrovascular Accident
1%
Concussion
1%
Endocarditis
1%
Right Ventricular Failure
1%
Hepatic Failure
1%
Diverticulitis
1%
Multi-Organ Failure
1%
Aortic Stenosis
1%
Intestinal Ischaemia
1%
Spinal Fracture
1%
Back Pain
1%
Bladder Neoplasm
1%
Blood Electrolytes Abnormal
1%
Bradycardia
1%
Muscular Weakness
1%
Osteoarthritis
1%
Angina Unstable
1%
B-Cell Lymphoma
1%
Bleeding Varicose Vein
1%
Bronchitis
1%
Carotid Artery Stenosis
1%
Intervertebral Disc Compression
1%
Pulmonary Odema
1%
Respiratory Tract Infection Viral
1%
Septic Shock
1%
Peripheral Ischaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Guided by NT-proBNP
Not Guided by NT-proBNP
Trial Design
1Treatment groups
Experimental Treatment
Group I: Ramipril TreatmentExperimental Treatment1 Intervention
6 months treatment with the medication Ramipril
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ramipril
FDA approved
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
540 Previous Clinical Trials
1,144,665 Total Patients Enrolled
12 Trials studying Peripheral Arterial Disease
458 Patients Enrolled for Peripheral Arterial Disease
Iraklis I Pipinos, MDPrincipal InvestigatorUniversity of Nebraska
2 Previous Clinical Trials
87 Total Patients Enrolled
2 Trials studying Peripheral Arterial Disease
87 Patients Enrolled for Peripheral Arterial Disease
George P Casale, PhDPrincipal InvestigatorUniversity of Nebraska
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of severe blockage in the arteries leading to your kidneys on both sides.You have a history of long-term leg pain while walking.You have experienced angioedema from taking ACE inhibitors before, or you are allergic to ramipril or other ACE inhibitors.You have severe pain or tissue loss caused by peripheral artery disease.You recently had a blood clot or severe injury in your legs.Your ability to walk is limited by conditions other than leg pain, such as problems with your muscles or nerves, or issues with your heart or lungs.You are currently taking ACE inhibitors or angiotensin II receptor blockers.You have long-term kidney disease with a low estimated Glomerular Filtration Rate.You have a history of leg pain that limits your ability to exercise, and this has been confirmed by a screening walking test administered by a vascular surgeon.You have a condition that affects the blood flow in your arteries, which can be detected through certain tests.
Research Study Groups:
This trial has the following groups:- Group 1: Ramipril Treatment
Awards:
This trial has 5 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients are enrolled in the current experiment?
"Indeed, according to clinicaltrials.gov this medical trial is accepting applicants at the moment. It was first published on October 1st 2015 and most recently modified on November 4th 2022. The research team needs 70 participants from a single site for their investigation."
Answered by AI
What perils are associated with Ramipril Treatment?
"Our team have rated the safety of Ramipril Treatment with a score of 3, which is indicative of its approval after completing Phase 4 trials."
Answered by AI
What criteria must one fulfill to be considered for enrollment in this experiment?
"This clinical trial is currently accepting 70 volunteers that have peripheral arterial disease and are between 18 to 90 years old."
Answered by AI
Is eligibility for this medical trial limited to individuals who are over 35 years of age?
"This clinical trial is available to individuals aged 18 and over, with a maximum age of 90."
Answered by AI
What medical issues is Ramipril Treatment typically used to address?
"Ramipril Treatment is an option for patients whose symptoms can be managed with the combined use of different medications. This drug has also been utilized to treat heart failure, diabetes-related kidney disease, and cardiovascular issues."
Answered by AI
Are any additional participants being accepted for this trial?
"According to the clinicaltrials.gov records, this trial is currently in its recruitment phase; it was initially posted on October 1st 2015 and last modified on November 4th 2022."
Answered by AI
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