Mathematical modeling of the impact of 'PCSK9 inhibitior'-drugs on the fat metabolism in patients with an impaired fat metabolism

Phase 1

• Conditions: dyslipidemia; MedDRA version: 19.1 Level: HLGT Classification code 10013317 Term: Lipid metabolism disorders System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003551-30-DE
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-27
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

•Age >=18
• written consent
•Criteria for a therapy with PSCK9 inhibitors are given

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.severe Liver-disease g (Child-Pugh C)
2. severe renal insufficiency
3.TSH not im reference range
4. uncontrolled aterial hypertension: Diastolic RR >=105 mmHg and/or systolic RR >=160 mmHg.
5.alcohol abuse or other drug abuse (except smoking)
6. blood donation within the last 6 weeks before the screening
7. Patients with a severe acute disease
8.HbA1c > 8.0%
9. Other important severe internistic diseases, which may alter the lipidmetabolism
10.hypersensitivity against the substance
11.pregnancy oder planned pregnancy and lactation period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified