Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01731990
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab (ACZ885) — DRUG
    Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
  • Placebo — DRUG
    Matching placebo of Canakinumab

Study Details

This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.

Key Dates

Start date
Oct 30, 2012
Status verified
Apr 2025
Primary completion
Aug 4, 2016
Completion
Aug 4, 2016

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab (ACZ885)
    Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
  • Placebo Comparator: Placebo
    Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months

Primary Outcome Measure

Mean Vessel Wall Area Ratio of 12 Months to Baseline [ Time Frame: Baseline, 12 months post-dose ]

Locations (8)

FacilityCityStateZIPSite coordinators
Novartis Investigative SitePhoenixArizona85302-
Novartis Investigative SiteJacksonvilleFlorida32207-
Novartis Investigative SiteJacksonvilleFlorida32216-
Novartis Investigative SiteChicagoIllinois60611-
Novartis Investigative SiteLuthervilleMaryland21093-
Novartis Investigative SiteColumbusOhio43215-
Novartis Investigative SiteKnoxvilleTennessee37920-
Novartis Investigative SiteRichmondVirginia23294-

Find similar trials in Phoenix, AZ

By condition
Peripheral artery disease
By specialty
CardiologyVascular medicine
By research site
Novartis Investigative Site· Phoenix, AZNovartis Investigative Site· Jacksonville, FLNovartis Investigative Site· Chicago, ILNovartis Investigative Site· Lutherville, MDNovartis Investigative Site· Columbus, OHNovartis Investigative Site· Knoxville, TN

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