Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062556
Status:
COMPLETED
Last Update Posted:
2006-11-01
First Post:
2003-06-09
Brief Title:
Effect of Niacin ERLovastatin on Peak Walking Time Claudication Onset Time in Patients With Intermittent Claudication
Sponsor:
Kos Pharmaceuticals
Organization:
Kos Pharmaceuticals
Study Overview
Official Title:
Effect of Niacin ERLovastatin on Peak Walking Time and Claudication Onset Time in Patients With Intermittent Claudication
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate if Niacin ERLovastatin at two different doses compared to diet control this group will receive a tablet containing 50 mg of immediate-release niacin is a safe and effective medicine in subjects with leg pain caused by a narrowing of their leg arteries a condition called intermittent claudication
At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study
Niacin ERLovastatin is a combination of two FDA United States Food and Drug Administration approved cholesterol modifying medications Niaspan extended-release niacin and lovastatin a statin the same medicine found in Mevacor Niacin ERLovastatin was approved by the FDA under the name of Advicor for use in the treatment of elevated cholesterol The use of Niacin ERLovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational An investigational use is one that is not approved by the FDA
At least 366 subjects with leg pain caused by a narrowing of their leg arteries will participate in this study
Niacin ERLovastatin is a combination of two FDA United States Food and Drug Administration approved cholesterol modifying medications Niaspan extended-release niacin and lovastatin a statin the same medicine found in Mevacor Niacin ERLovastatin was approved by the FDA under the name of Advicor for use in the treatment of elevated cholesterol The use of Niacin ERLovastatin in the treatment of peripheral arterial disease and symptomatic relief of intermittent claudication is considered investigational An investigational use is one that is not approved by the FDA
Detailed Description:
This is a Phase 3 28-week double-blind diet-intervention randomized parallel group three-arm multi-center dose-titration study
The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC The primary efficacy analysis will be the percent change from baseline in Peak Walking Time PWT and Claudication Onset Time COT calculated as the logarithm of the quotient of the time walked on treadmill at a visit divided by the time walked at baseline Other efficacy measures will include Ankle Brachial Index ABI QoL measurements composite of cardiovascular events MI stroke vascular death and lower limb amputations and coronary and peripheral artery revascularization procedures Safety variables will include serum transaminases routine chemistry parameters hematology and AEs Pharmacokinetic analyses will be conducted as well
The objectives of this study are to evaluate the safety and efficacy of NL in patients with IC The primary efficacy analysis will be the percent change from baseline in Peak Walking Time PWT and Claudication Onset Time COT calculated as the logarithm of the quotient of the time walked on treadmill at a visit divided by the time walked at baseline Other efficacy measures will include Ankle Brachial Index ABI QoL measurements composite of cardiovascular events MI stroke vascular death and lower limb amputations and coronary and peripheral artery revascularization procedures Safety variables will include serum transaminases routine chemistry parameters hematology and AEs Pharmacokinetic analyses will be conducted as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ICPOP | None | None | None |