NCT04507373 is a Phase 4 clinical trial of Simvastatin 40mg in Muscle Cramp, sponsored by University of Texas Southwestern Medical Center.

Who is sponsoring NCT04507373?

NCT04507373 is sponsored by University of Texas Southwestern Medical Center.

What drugs are being tested in NCT04507373?

Interventions in NCT04507373: Simvastatin 40mg.

What condition does NCT04507373 study?

NCT04507373 studies Muscle Cramp, Ache, Weakness, Muscle, Statin Adverse Reaction.

Is NCT04507373 still recruiting?

NCT04507373 is currently terminated. Last updated 14 February 2023.

Are results published for NCT04507373?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-02-14 · How we verify

NCT04507373

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events

Terminated Phase 4 Results posted Last updated 14 February 2023

What this trial tests

Phase 4 trial testing Simvastatin 40mg in Muscle Cramp in 3 participants. Terminated before completion.

Timeline

17 August 2018

Primary endpoint
20 December 2021

20 December 2021

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	basic science
Enrollment	3
Start date	17 August 2018
Primary completion	20 December 2021
Estimated completion	20 December 2021
Sites	1 location across United States

Drugs / interventions tested

Simvastatin 40mg — full drug profile →

Conditions studied

Muscle Cramp — all drugs for Muscle Cramp →
Ache — all drugs for Ache →
Weakness, Muscle — all drugs for Weakness, Muscle →
Statin Adverse Reaction — all drugs for Statin Adverse Reaction →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 80, any sex, with Muscle Cramp or Ache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g. pain, aches, weakness, cramps, or stiffness) (1, 2). The pathophysiology of these statin-associated muscle symptoms (SAMS) has remained elusive. Consequently, no objective diagnostic method exists, causing confusion for patient and providers since muscle symptoms can often be multifactorial.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Simvastatin 40mg

Trials testing the same drug.

NCT06379958 — Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects · Phase 1 · recruiting
NCT05586360 — T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer · Phase 2 · recruiting
NCT04457089 — Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer · EARLY_PHASE1 · completed
NCT03654053 — Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Ri · Phase 3 · active not recruiting
NCT04133792 — Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) · Phase 3 · active not recruiting

Other recruiting trials for Muscle Cramp

Currently open trials in the same condition.

NCT03660969 — Reliability of Cardiac Troponins for the Diagnosis of Myocardial Infarction in the Presence of Skeletal Muscle Disease · active not recruiting

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

NCT03849963 — Imaging Oxidative Metabolism and Neurotransmitter Synthesis in the Human Brain · recruiting
NCT06917183 — Developing Strategies for Implementation and Use of the Operating Room Black Box (ORBB) · NA · not yet recruiting
NCT05145309 — Value of Potassium Magnesium Citrate in Preventing and Treating Hypertension in African Americans · Phase 2 · not yet recruiting
NCT06552000 — Pre-operative Tumor Treating Fields in Patients With Resectable Lung Cancer · NA · not yet recruiting
NCT07387666 — Imaging Acetadote Metabolism in Glioblastoma · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04507373 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Texas Southwestern Medical Center
Last refreshed: 14 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04507373.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing