Clinical trial • Phase IV • Musculoskeletal | Cardiology | Other

Pravastatin sodium for Hypercholesterolemia | Cardiovascular risk requiring primary or secondary prevention

Phase IV trial of Pravastatin sodium for Hypercholesterolemia | Cardiovascular risk requiring primary or secondary prevention.

Overview

Trial Therapeutic Area
Musculoskeletal | Cardiology | Other
Trial Disease
Hypercholesterolemia | Cardiovascular risk requiring primary or secondary prevention
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
07-02-2024
First CTIS Authorization Date
19-02-2024

Trial design

Control: usual clinical practice (statin prescription per routine care). Intervention: statin prescribed based on prospective genotyping of SLCO1B1, ABCG2 and CYP2C9 (genotype-guided prescription). Phase IV trial across 2 sites in Spain.

Comparator
Control: usual clinical practice (statin prescription per routine care). Intervention: statin prescribed based on prospective genotyping of SLCO1B1, ABCG2 and CYP2C9 (genotype-guided prescription).
Real World Control
Yes
Biomarker Stratified
True, SLCO1B1; ABCG2; CYP2C9 (genotype-guided prescription)
Target Sample Size
1000
Trial Duration For Participant
180

Eligibility

Recruits 1000 Not a vulnerable population; adults (>18 years). Written informed consent required from participants..

Pregnancy Exclusion
d) Pregnant or breast-feeding patients.
Vulnerable Population
Not a vulnerable population; adults (>18 years). Written informed consent required from participants.

Inclusion criteria

  • {"criterion_text":"- a)\tIn which it is indicated statins as a treatment at any dose.\n- b)\tPacients who must be outpatients, recruited in a health care centre (primary attention) or in hospitals (primary or secundary prevention).\n- c)\tPacients who must have never taken statins or who have started statin treatment less tan 15 days ago, or who had their statin dose increased or changed to a more potent statin due to bad control of LDL levels in the last 15 days.\n- d)\tPatients who have to give their inform consent form written"}

Exclusion criteria

  • {"criterion_text":"- a)\tPacients who statins are not prescribed as standard clinical practice.\n- b)\tPacients who suffer a malignant or terminal disease whose live expectancy will be less than 6 months.\n- c)\tPacients who have statins contraindicated for treatment\n- d)\tPregnant or breast-feeding patients."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The incidence of musculoskeletal adverse reactions induced during the first 6 months of treatment (measurement at 6 months).","definition_or_measurement_approach":"Measured as incidence of musculoskeletal adverse reactions during the first 6 months of treatment; measurement at 6 months."}

Secondary endpoints

  • {"endpoint_text":"- The incidence of musculoskeletal adverse reactions at 12 months or longer follow up.","definition_or_measurement_approach":"Measured as incidence of musculoskeletal adverse reactions at 12 months or longer follow-up."}

Recruitment

Planned Sample Size
1000
Recruitment Window Months
22
Consent Approach
Written informed consent required from participants; adults (>18) provide consent. No assent process or languages for consent specified.

Methods

  • Recruitment of outpatients in health care centres (primary care) and hospitals (Hospital Universitario De La Princesa) in Spain; patients identified at point of care when statin treatment is indicated.

Geography

Total Number Of Sites
2
Total Number Of Participants
1000

Spain

Earliest CTIS Part Ii Submission Date
07-02-2024
Latest Decision Or Authorization Date
19-02-2024
Processing Time Days
12
Number Of Sites
2
Number Of Participants
1000

Sites

Site Name
Gerencia Asistencial de Atención Primaria
Department Name
Gerencia Asistencial de Atención Primaria
Contact Person Name
José Manuel Izquierdo Palomares
Site Name
Hospital Universitario De La Princesa
Department Name
IP Hospital Universitario de La Princesa
Contact Person Name
Susana Almenara de Riquer

Sponsor

Primary sponsor

Full Name
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Princesa
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
PRAVASTATIN
Active Substance
Pravastatin sodium
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
40 mg
Investigational Product Name
ATORVASTATIN
Active Substance
Atorvastatin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
80 mg
Investigational Product Name
PITAVASTATIN
Active Substance
Pitavastatin calcium
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
4 mg
Investigational Product Name
FLUVASTATIN
Active Substance
Fluvastatin sodium
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
80 mg
Investigational Product Name
ROSUVASTATIN
Active Substance
Rosuvastatin zinc
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
prodAuthStatus: 2
Maximum Dose
40 mg

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