Dose-escalating Safety Study in Subjects on Stable Statin Therapy
1 agosto 2016 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Tipo di studio
Interventistico
Iscrizione (Effettivo)
74
Fase
- Fase 2
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Amsterdam, Olanda, 1105 AZ
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Leiden, Olanda, 2311 GZ
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Rotterdam, Olanda, 3021 HC
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Utrecht, Olanda, 3584 CX
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Maine
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Auburn, Maine, Stati Uniti, 04210
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 65 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Coorte A
Dosi di carico seguite da dosi di mantenimento settimanali
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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
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Sperimentale: Coorte B
Dosi di carico seguite da dosi di mantenimento settimanali
|
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
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Sperimentale: Coorte C
Dosi di carico seguite da dosi di mantenimento settimanali
|
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
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Sperimentale: Cohort D
Loading doses followed by weekly maintenance doses
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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
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Sperimentale: Cohort E
Loading doses followed by weekly maintenance doses
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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
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Sperimentale: Cohort F
Loading doses followed by extended weekly maintenance doses
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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
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Sperimentale: Cohort G
Loading doses followed by extended weekly maintenance doses
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percent reduction in LDL-cholesterol from baseline
Lasso di tempo: From baseline measurement
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From baseline measurement
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Percent reduction in apoB-100
Lasso di tempo: From baseline measurement
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From baseline measurement
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Percent change in HDL-cholesterol, triglycerides, total cholesterol, non-HDL cholesterol, VLDL plus LDL-cholesterol and LDL-cholesterol particle size and concentration
Lasso di tempo: From baseline measurement
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From baseline measurement
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Percent change from baseline in LDL/HDL and apoB-100/apo-A1 ratios
Lasso di tempo: From baseline measurement
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From baseline measurement
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AEs, SAEs, physical examination data, vital signs, and laboratory analyzes
Lasso di tempo: Duration of study
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Duration of study
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2005
Completamento primario (Effettivo)
1 giugno 2007
Completamento dello studio (Effettivo)
1 dicembre 2007
Date di iscrizione allo studio
Primo inviato
3 ottobre 2005
Primo inviato che soddisfa i criteri di controllo qualità
3 ottobre 2005
Primo Inserito (Stima)
4 ottobre 2005
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
3 agosto 2016
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 agosto 2016
Ultimo verificato
1 dicembre 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 301012CS4
- EudraCT No.: 2005-002119-26
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .