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New registry aims to unravel mysteries of statin side effects

NCT ID NCT04975594

Knowledge-focused Sponsor: University of Leipzig Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry is following 1,000 people who have trouble tolerating statins, a common cholesterol-lowering drug. Researchers will track how often treatments are changed, cholesterol levels, and quality of life over time. The goal is to better understand this condition and improve heart disease prevention for those affected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this registry could help doctors better manage cholesterol in people who cannot take statins, potentially reducing heart disease risk.
What could go wrong
This is an observational registry, not a treatment trial, so it will not directly test any new drug or therapy. Results may not lead to immediate changes in care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with statin-intolerance

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients with dyslipidemia and statin intolerance, defined as: Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued 2. Participants are ≧ 18 years old 3. Written declaration of consent is available 4. The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely. Exclusion Criteria: 1. Use of any experimental or investigational drugs within 30 days prior to screening. 2. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.

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Conditions

The condition(s) this trial relates to.

Dyslipidemias hyperlipidemia inherited lipid metabolism disorder Lipid Metabolism Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dyslipidemias

Contacts and locations

Locations

  • Uniklinik Leipzig

    Leipzig, Saxony, 04103, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.