- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00231569
Dose-escalating Safety Study in Subjects on Stable Statin Therapy
1. august 2016 oppdatert av: Kastle Therapeutics, LLC
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety and Pharmacodynamics of ISIS 301012 in Hypercholesterolemic Subjects on Stable Statin Therapy
The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on Stable statin therapy.
Studieoversikt
Status
Fullført
Forhold
Studietype
Intervensjonell
Registrering (Faktiske)
74
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maine
-
Auburn, Maine, Forente stater, 04210
-
-
-
-
-
Amsterdam, Nederland, 1105 AZ
-
Leiden, Nederland, 2311 GZ
-
Rotterdam, Nederland, 3021 HC
-
Utrecht, Nederland, 3584 CX
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- On a stable dose of >/= 40 mg Simvastatin or atorvastatin daily for >/= 3 months prior to baseline and expected to remain on this dose for the remainder of the study
- LDL-cholesterol between 2.60 and 5.70 mmol/L (100 and 220 mg/dL), inclusive at screening
- Females not of childbearing potential.
Exclusion Criteria:
- History of CHD or CHD-equivalent (such as diabetes mellitus, or another clinical form of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic aneurysm, or symptomatic carotid artery disease)
- Fasting triglyceride >2.26 mmol/L (200 mg/dL) at screening
- Any uncontrolled medical/surgical/psychiatric condition, including conditions that may predispose to secondary hypercholesterolemia
- Current diagnosis or known history of complement deficiency or abnormality
- A positive hepatitis B surface antigen or hepatitis C antibody, or a known positive HIV status
- Current diagnosis or known history of liver disease, or has an ALT >ULN at screening
- Known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or has a CPK >ULN at screening
- Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated
- The advisability of a subject taking any prescription medication (apart from simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed with the Isis Medical Monitor
- Subject unwilling to discontinue taking alternative/herbal medication for the duration of the study
- History of drug abuse within 2 years of screening
- Subject unwilling to limit alcohol consumption for the duration of the study: male subjects to a maximum of 3 drinks (30 g) per day, and <12 drinks (120 g) per week; female subjects to a maximum of 2 drinks (20 g) per day, and <8 drinks (80 g) per week
- Known allergy or hypersensitivity to simvastatin
- Undergoing or has undergone treatment with another investigational drug, biologic agent, or device within 3 months, or 3 half lives, prior to screening, whichever is longer
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Kohort A
Ladedoser etterfulgt av ukentlige vedlikeholdsdoser
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Eksperimentell: Kohort B
Ladedoser etterfulgt av ukentlige vedlikeholdsdoser
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Eksperimentell: Kohort C
Ladedoser etterfulgt av ukentlige vedlikeholdsdoser
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Eksperimentell: Cohort D
Loading doses followed by weekly maintenance doses
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Eksperimentell: Cohort E
Loading doses followed by weekly maintenance doses
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Eksperimentell: Cohort F
Loading doses followed by extended weekly maintenance doses
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Eksperimentell: Cohort G
Loading doses followed by extended weekly maintenance doses
|
30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent reduction in LDL-cholesterol from baseline
Tidsramme: From baseline measurement
|
From baseline measurement
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Percent reduction in apoB-100
Tidsramme: From baseline measurement
|
From baseline measurement
|
Percent change in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL plus LDL-cholesterol and LDL-cholesterol particle size and concentration
Tidsramme: From baseline measurement
|
From baseline measurement
|
Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios
Tidsramme: From baseline measurement
|
From baseline measurement
|
AEs, SAEs, physical examination data, vital signs, and laboratory analyzes
Tidsramme: Duration of study
|
Duration of study
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2005
Primær fullføring (Faktiske)
1. juni 2007
Studiet fullført (Faktiske)
1. desember 2007
Datoer for studieregistrering
Først innsendt
3. oktober 2005
Først innsendt som oppfylte QC-kriteriene
3. oktober 2005
Først lagt ut (Anslag)
4. oktober 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
3. august 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. august 2016
Sist bekreftet
1. desember 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 301012CS4
- EudraCT No.: 2005-002119-26
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på ISIS 301012 or Placebo
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Fullført
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Fullført
-
Devintec SaglMeditrial SrLRekrutteringTilbakevendende aftøst sårItalia
-
Ornovi, Inc.Tilbaketrukket
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.FullførtHyperkolesterolemi | Koronar hjertesykdomSør-Afrika, Tyskland, Forente stater, Storbritannia, Canada, Tsjekkisk Republikk
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.Fullført
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.FullførtHyperkolesterolemi, familiærForente stater, Nederland
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.FullførtKoronararteriesykdom | Heterozygot familiær hyperkolesterolemiForente stater, Canada
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.FullførtMetabolske sykdommer | Medfødte abnormiteter | Spedbarn, nyfødte, sykdommer | Genetiske sykdommer, medfødte | Dyslipidemier | Metabolisme, medfødte feil | Lipidmetabolismeforstyrrelser | Hyperkolesterolemi | Hyperlipidemier | Hyperlipoproteinemier | Lipidmetabolisme, medfødte feil | Hyperlipoproteinemi type II | Metabolsk... og andre forholdForente stater, Taiwan, Brasil, Canada, Sør-Afrika, Storbritannia, Singapore
-
Kastle Therapeutics, LLCIonis Pharmaceuticals, Inc.FullførtMetabolske sykdommer | Dyslipidemier | Lipidmetabolismeforstyrrelser | Hyperkolesterolemi | Hyperlipidemier | Metabolsk forstyrrelseNederland