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HMG-CoA reductase inhibitor

Lipitor 20Mg Tablet for Cardiovascular Disease

Phase 4

Waitlist Available

Led By John Thyfault, PhD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>5% risk for a cardiovascular event in the next 10 years according to the 2013 American College of Cardiology/American Heart Association risk calculator and/or 2 out of 5 metabolic syndrome risk factors(Triglycerides ≥ 150 mg/dL; HDL ≤ 40 mg/dL; Glucose ≥ 100mg/dL; Waist Circumference ≥ 102cm for males, 88cm for females; Blood pressure: ≥ 130mmHg systolic and/or 85mmHg diastolic or being treated for hypertension)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to week 12

Awards & highlights

Study Summary

This trial will test how different doses of a statin affects muscle health and exercise ability.

Who is the study for?

This trial is for adults at risk of heart disease, with a BMI between 25-43 and leading a sedentary lifestyle. They should have stable medication doses and be willing to pause NSAIDs and aspirin before muscle tests. Those who've had significant weight changes or are very active aren't eligible.Check my eligibility

What is being tested?

The study examines how high (80mg) and low (20mg) doses of Lipitor—a cholesterol-lowering drug—alongside an exercise program affect muscle health compared to a placebo in individuals at risk for cardiovascular disease.See study design

What are the potential side effects?

Possible side effects from Lipitor may include muscle pain, fatigue, headache, digestive issues like constipation or diarrhea, and increased liver enzymes which might indicate liver strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at a high risk for heart disease in the next 10 years or have at least 2 metabolic syndrome risk factors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oxygen Consumption

Secondary outcome measures

Citrate synthase activity

Insulin sensitivity

Mitochondrial respiratory function

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Low Statin & Exercise GroupExperimental Treatment2 Interventions

Participants randomized to this group will undergo low statin treatment (Lipitor 20Mg Tablet) and an aerobic exercise program.

Group II: High Statin & Exercise GroupExperimental Treatment2 Interventions

Participants randomized to this group will undergo high statin treatment (Lipitor 80Mg Tablet) and an aerobic exercise program.

Group III: Placebo & Exercise GroupPlacebo Group2 Interventions

Participants randomized to this group will undergo placebo treatment and an aerobic exercise program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lipitor 20Mg Tablet

2018

Completed Phase 4

~70

Lipitor 80Mg Tablet

2018

Completed Phase 4

~70

Exercise Program

2016

Completed Phase 3

~4930

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

483 Previous Clinical Trials

1,086,821 Total Patients Enrolled

University of Kansas Medical CenterLead Sponsor

461 Previous Clinical Trials

169,038 Total Patients Enrolled

John Thyfault, PhDPrincipal InvestigatorUniversity of Kansas Medical Center

2 Previous Clinical Trials

79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this experiment?

"Affirmative. According to clinicaltrials.gov, this experiment is actively searching for participants; it was posted on February 1st 2018 and last updated on May 2nd 2022. The research requires 120 individuals from one medical site."

Answered by AI

Is the age limit for participation in this trial beyond fifty years of age?

"Qualified applicants for this particular trial must be between 35 and 65 years old. According to the available data, there are 32 studies that involve participants under 18 while 433 trials recruit those above 65."

Answered by AI

What ailments is Exercise Program often prescribed for?

"Exercise Program is often utilised to alleviate lipidemias, though it may also be beneficial for treating postoperative thromboembolism, anginal pain, and transient ischemic attack."

Answered by AI

Do I meet the requirements to become a participant in this research endeavor?

"To be considered for this clinical trial, an individual must have a cardiovascular condition and lie within the age bracket of 35 to 65. The recruitment process will involve 120 participants in total."

Answered by AI

Are there any potential risks associated with participating in this Exercise Program?

"Our assessment of the Exercise Program's safety was determined to be a 3 due to its Phase 4 status, signifying that it has been approved."

Answered by AI

Has a comparable experiment ever been conducted before?

"Currently, 70 extant studies focusing on Exercise Program are in progress across 162 cities and 28 countries. The inaugural study commenced back in 2005, organised by Merck Sharp & Dohme LLC with 80 participants, culminating at the fourth phase of drug approval. Since then, 18729 clinical trials have been conducted related to this program."

Answered by AI

Are there any available slots in this research protocol for participants?

"According to clinicaltrials.gov, this research initiative is still searching for participants. It was initially uploaded on February 1st 2018 and the latest update came in at May 2nd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Impact of Statin Therapy on Adaptations to Aerobic Exercise

2018. "Impact of Statin Therapy on Adaptations to Aerobic Exercise". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03360916.

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