A Phase III Study to Assess the Effect of FDC Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on LDL-C in LLT-naïve Patients
A Phase III, Randomised, Double-Blind, Factorial Design Study to Assess the Effect of Fixed Dose Combination Laroprovstat/Rosuvastatin Compared With Laroprovstat, Rosuvastatin, and Placebo on Low-Density Lipoprotein Cholesterol in Lipid-Lowering Treatment-Naïve Patients
The purpose of this study is to evaluate the effect on LDL-C and the safety and tolerability of FDC laroprovstat/rosuvastatin in LLT-naïve patients with hypercholesterolaemia. Laroprovstat and FDC laroprovstat/rosuvastatin are being developed for the treatment of hypercholesterolaemia.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 3
Kontakter og plasseringer
Studiekontakt
- Navn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 9479 +1877240
- E-post: information.center@astrazeneca.com
Studiesteder
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Hong Kong, Hong Kong
- Research Site
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Hong Kong, Hong Kong, 00000
- Research Site
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Hong Kong, Hong Kong, 999077
- Research Site
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Beijing, Kina, 102218
- Research Site
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Chifeng, Kina, 024000
- Research Site
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Guangzhou, Kina, 510220
- Research Site
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Hangzhou, Kina, 310009
- Research Site
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Ha’erbin, Kina, 150001
- Research Site
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Hefei, Kina, 230601
- Research Site
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Liuzhou, Kina, 545006
- Research Site
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Luoyang, Kina, 471003
- Research Site
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Nanchang, Kina, 330009
- Research Site
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Nanjing, Kina, 210011
- Research Site
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Sanya, Kina, 572000
- Research Site
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Shanghai, Kina, 200032
- Research Site
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Shantou, Kina, 515065
- Research Site
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Shiyan, Kina, 442099
- Research Site
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Suining, Kina, 629000
- Research Site
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Tangshan, Kina, 63000
- Research Site
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Tianjin, Kina, 300000
- Research Site
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Yueyang, Kina, 414000
- Research Site
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Zhengzhou, Kina, 450000
- Research Site
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Zigong, Kina, 643000
- Research Site
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Ampang, Malaysia, 68000
- Research Site
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Beseri, Malaysia, 02400
- Research Site
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Kuala Kedah, Malaysia, 06600
- Research Site
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Puchong, Malaysia, 47100
- Research Site
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Sarawak Miri, Malaysia, 98000
- Research Site
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Daegu, Sør -Korea, 42601
- Research Site
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Seoul, Sør -Korea, 134-727
- Research Site
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Seoul, Sør -Korea, 143-729
- Research Site
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Wŏnju, Sør -Korea, 26426
- Research Site
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Bangkok, Thailand, 10700
- Research Site
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Banphaeo, Thailand, 74120
- Research Site
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Chiang Mai, Thailand, 50200
- Research Site
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Phutthamonthon, Thailand, 73170
- Research Site
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Ratchathewi, Thailand, 10400
- Research Site
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Haiphong, Vietnam, 180000
- Research Site
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Ho Chi Minh City, Vietnam, 700000
- Research Site
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Hochiminh, Vietnam, 700000
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Hochiminh City, Vietnam, 700000
- Research Site
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Hà Nội, Vietnam, 100000
- Research Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Participant must be ≥ 18 years of age
- Participants with no clinical history of ASCVD and a 10-year ASCVD risk estimated as low
- Participants who have not received any LLT in the 3 months prior to screening
- Participants of Asian origin.
Exclusion Criteria:
- Statin intolerance
- Uncontrolled severe hypertension
- Uncontrolled type 2 diabetes mellitus
- Inadequately treated hypothyroidism
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Faktoriell oppgave
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Aktiv komparator: Laroprovstat
The patient will receive a daily dose of Laroprovstat. |
daily oral dose of the Laroprovstat daily oral dose of the Placebo to match Rosuvastatin |
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Aktiv komparator: Rosuvastatin Dose 1
The patient will receive a daily dose of Rosuvastatin 1. |
daily oral dose of the Rosuvastatin 1
Andre navn:
daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
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Aktiv komparator: Rosuvastatin Dose 2
The patient will receive a daily dose of Rosuvastatin 2. |
daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin daily oral dose of the Rosuvastatin 2 |
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Eksperimentell: FDC laroprovstat/rosuvastatin Dose combination 1
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 1. |
daily oral dose of the Placebo to match Rosuvastatin daily oral dose of the FDC Laroprovstat/Rosuvastatin 1 |
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Eksperimentell: FDC laroprovstat/rosuvastatin Dose combination 2
The patient will receive a daily dose of FDC Laroprovstat/Rosuvastatin 2. |
daily oral dose of the Placebo to match Rosuvastatin daily oral dose of the FDC Laroprovstat/Rosuvastatin 2 |
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Placebo komparator: Placebo
The patient will receive a daily dose of Placebo. |
daily oral dose of the Placebo to match Rosuvastatin daily oral dose of the Placebo to match laroprovstat or FDC laroprovstat/rosuvastatin |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Relative change in LDL-C
Tidsramme: Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 2 versus placebo, rosuvastatin Dose 2, and laroprovstat on LDL-C at Week 8. |
Week 8
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Relative change in LDL-C
Tidsramme: Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin Dose 1 versus placebo, rosuvastatin Dose 1, and laroprovstat on LDL-C at Week 8. |
Week 8
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Relative change in Apo B
Tidsramme: Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on Apo B at Week 8. |
Week 8
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Relative change in non-HDL-C
Tidsramme: Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on non-HDL-C at Week 8. |
Week 8
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Relative change in total cholesterol
Tidsramme: Week 8
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To compare the effect of treatment with FDC laroprovstat/rosuvastatin versus the individual components and placebo on total cholesterol at Week 8. |
Week 8
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Metabolske sykdommer
- Hyperlipidemier
- Dyslipidemier
- Lipidmetabolismeforstyrrelser
- Ernæringsmessige og metabolske sykdommer
- Hyperkolesterolemi
- Svovelforbindelser
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Hydrokarboner
- Amides
- Pyrimidiner
- Hydrokarboner, halogenert
- Sulfonamider
- Sulfoner
- Fluorbenzener
- Hydrokarboner, fluorert
- Rosuvastatin kalsium
Andre studie-ID-numre
- D7961C00006
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD-delingstidsramme
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Tilgangskriterier for IPD-deling
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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