Safety and Pharmacokinetis of TAP311 in Dyslipidemic Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Dyslipidaemia
In brief
The study will assess the safety, tolerability and pharmacokinetics of TAP311 in patients with dyslipidemia.
Key facts
- Study ID
- NCT01632358
- Run by
- Novartis Pharmaceuticals
- People needed
- 279
- Starts
- 2012-06-01
- Expected to finish
- 2012-12-01
- Last updated by the study team
- 2013-12-02
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male and female patients 18 to 80 years (inclusive) of age.
- Patients are not treated for dyslipidemia with medications other than HMG-CoA reductase inhibitors (statins) for at least 4 weeks prior to Day 1. Patients should be on stable doses of current medications, if any, for at least 3 months to be eligible.
- Patients must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2.
You may not qualify if…
- Use of other investigational drugs at the time of enrollment
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Use of lipid modifying agents (e.g. fenofibrate, niacin, omega-3 fatty acids, etc.) other than statins will exclude subjects.
- Pregnant or nursing (lactating) women
- Diabetic patients whose plasma glucose is not well controlled by stable diabetic treatment for at least 3 months
- Heavy smokers (smoke more than 10 cigarettes a day routinely and who cannot refrain from smoking during the study).
- Women of child-bearing potential (WOCBP) can be included but must use highly effective contraception
- Significant illness within two (2) weeks prior to initial dosing
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Where it is running
- Novartis Investigative Site — Miramar, Florida, United States
- Novartis Investigative Site — Amman, Jordan
- Novartis Investigative Site — Taichung, Taiwan, Taiwan
Full record on ClinicalTrials.gov
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