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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: AstraZeneca Clinical Study Information Center
- Telefonnummer: 9479 +1877240
- E-post: information.center@astrazeneca.com
Studieorter
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Hong Kong, Hong Kong
- Research Site
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Hong Kong, Hong Kong, 00000
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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, Sydkorea, 42601
- Research Site
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Seoul, Sydkorea, 134-727
- Research Site
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Seoul, Sydkorea, 143-729
- Research Site
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Wŏnju, Sydkorea, 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
- Research Site
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Hochiminh City, Vietnam, 700000
- Research Site
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Hà Nội, Vietnam, 100000
- Research Site
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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
Andra namn:
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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Experimentell: 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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Experimentell: 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-jämförare: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Relative change in LDL-C
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Relative change in Apo B
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Metaboliska sjukdomar
- Hyperlipidemier
- Dyslipidemier
- Lipidmetabolismstörningar
- Närings- och metabola sjukdomar
- Hyperkolesterolemi
- Svavelföreningar
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Kolväten
- Amider
- Pyrimidiner
- Kolväten, halogenerad
- Sulfonamider
- Sulfoner
- Fluorobenzen
- Kolväten, fluorerad
- Rosuvastatin kalcium
Andra studie-ID-nummer
- D7961C00006
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
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