Clinical trial • Cardiology|Endocrinology

Roxadustat for Cardiovascular disease risk factors|Metabolic syndrome

Clinical trial of Roxadustat for Cardiovascular disease risk factors|Metabolic syndrome. PLACEBO (oral tablet), dose not specified-controlled.

Overview

Trial Therapeutic Area
Cardiology|Endocrinology
Trial Disease
Cardiovascular disease risk factors|Metabolic syndrome
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
19-12-2023
First CTIS Authorization Date
12-04-2024

Trial design

PLACEBO (oral tablet), dose not specified-controlled trial across 1 site in Finland.

Comparator
PLACEBO (oral tablet), dose not specified
Target Sample Size
24

Eligibility

Recruits 24 No vulnerable population selected (isVulnerablePopulationSelected: false). No additional consent or assent handling described..

Pregnancy Exclusion
Pregnancy or breast feeding
Vulnerable Population
No vulnerable population selected (isVulnerablePopulationSelected: false). No additional consent or assent handling described.

Inclusion criteria

  • {"criterion_text":"- Body mass index over 20 kg/m2 and body weight below 100 kg\n- Good general health based upon the results of the medical history, laboratory tests, physical examination, and 12-lead ECG as assessed by the investigator"}

Exclusion criteria

  • {"criterion_text":"- Regular medication (not including hormonal intrauterine device)\n- Previous venous thrombosis or previous convulsions\n- Family history of significant venous thrombosis\n- Familial galactose intolerance, total lactase deficiency or absorbtion deficiency of glucose and galactose\n- Allergy to peanut or soy\n- Unable to speak Finnish\n- Significant surgery 6 months before trial\n- Participation in another clinical trial one month before beginning of the trial\n- Abuse of alcohol or medicines or use of drugs\n- Fear of pricking and previous difficult blood sampling\n- Significant diseases\n- Systolic blood pressure over 150 mmHg\n- Hemoglobin levels above Finnish reference values\n- Pregnancy or breast feeding\n- WOCBP not using very potent contraception during study periods and one week after"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Plasma total cholesterol levels","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Plasma LDL cholesterol and triglyceride levels","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Insulin resistance and glucose tolerance","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Body composition","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Blood pressure","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Skeletal muscle microcirculation","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
24
Recruitment Window Months
23

Geography

Total Number Of Sites
1
Total Number Of Participants
24

Finland

Earliest CTIS Part Ii Submission Date
22-03-2024
Latest Decision Or Authorization Date
14-04-2024
Processing Time Days
23
Number Of Sites
1
Number Of Participants
24

Sites

Site Name
Pohjois-Pohjanmaan hyvinvointialue
Department Name
Research Unit of Internal Medicine
Principal Investigator Name
Janne Hukkanen
Principal Investigator Email
janne.hukkanen@oulu.fi
Contact Person Name
Janne Hukkanen
Contact Person Email
janne.hukkanen@oulu.fi
Number Of Participants
24

Sponsor

Primary sponsor

Full Name
Pohjois-Pohjanmaan hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
Evrenzo 70 mg film-coated tablets
Active Substance
Roxadustat
Modality
Small molecule
Routes Of Administration
oral
Route
oral
Authorisation Status
Authorised (marketing authorisation EU/1/21/1574/008)
Maximum Dose
400 mg
Investigational Product Name
PLACEBO
Active Substance
PLACEBO
Modality
Other
Routes Of Administration
oral
Route
oral
Maximum Dose
0 mg

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