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NCT00751608 Clinical Trial

Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients

Familial Hypercholesterolemia Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00751608
Other study ID # CAPL180A2207
Secondary ID
Status Withdrawn
Phase Phase 2
First received September 11, 2008
Last updated September 22, 2016
Start date September 2006
Est. completion date February 2009

Study information
Verified date September 2016
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial Summary

This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Confirmed presence of familial hypercholesterolemia

- Women must be sterilized or post-menopausal

Exclusion Criteria:

- Smoking an average of greater than 10 cigarettes per day

- History of cardiac events

- Very low or high body weight

- Treatment with fibrates or niacin

- High blood triglyceride levels

Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• APL180

• APL180

• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Outcome
Type Measure Description Time frame Safety issue
Primary Change in forearm blood flow during each treatment
See also
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