Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071266
Status:
COMPLETED
Last Update Posted:
2006-11-02
First Post:
2003-10-16
Brief Title:
The Dose Response of Niacin ERLovastatin on Peak Walking Time PWT in Patients With Intermittent Claudication - TROPIC
Sponsor:
Kos Pharmaceuticals
Organization:
Kos Pharmaceuticals
Study Overview
Official Title:
The Dose Response of Niacin ERLovastatin on Peak Walking Time PWT in Patients With Intermittent Claudication - a Matrix Design
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 compare the dose response and safety of Niacin ERLovastatin Niaspan and Lovastatin with each other in subjects with leg pain caused by a narrowing of their leg arteries
At least 870 subjects with leg pain caused by a narrowing of their leg arteries will take part in this study
Both Niaspan and lovastatin Mevacor are approved by the United States Food and Drug Administration FDA to treat high cholesterol Niacin ERLovastatin Advicor a combination of these two drugs is also approved by the FDA to treat high cholesterol The use of Niacin ERLovastatin to treat narrowing of leg arteries and relieve intermittent claudication leg pain caused by narrowing of the arteries in the leg is considered investigational An investigational use is one that is not approved by the FDA
At least 870 subjects with leg pain caused by a narrowing of their leg arteries will take part in this study
Both Niaspan and lovastatin Mevacor are approved by the United States Food and Drug Administration FDA to treat high cholesterol Niacin ERLovastatin Advicor a combination of these two drugs is also approved by the FDA to treat high cholesterol The use of Niacin ERLovastatin to treat narrowing of leg arteries and relieve intermittent claudication leg pain caused by narrowing of the arteries in the leg is considered investigational An investigational use is one that is not approved by the FDA
Detailed Description:
This is a Phase 3 32-week double-blind diet-intervention randomized parallel group ten-arm multi-center multi-national dose titration study evaluating the safety and efficacy of NL in patients with intermittent claudication IC
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 calculated from the natural logarithm of the ratio of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline Other efficacy measures will include Claudication Onset Time COT percent changes from baseline to Week 32 changes in Ankle Brachial Index ABI Quality of Life QoL percent changes at Weeks 20 and 32 lower limb amputations composite of cardiovascular events MI stroke and vascular death and coronary and peripheral artery revascularizations Safety variables will include serum transaminases routine chemistry parameters hematology and adverse events 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 calculated from the natural logarithm of the ratio of the time walked on treadmill at the Week 32 Visit divided by the time walked at baseline Other efficacy measures will include Claudication Onset Time COT percent changes from baseline to Week 32 changes in Ankle Brachial Index ABI Quality of Life QoL percent changes at Weeks 20 and 32 lower limb amputations composite of cardiovascular events MI stroke and vascular death and coronary and peripheral artery revascularizations Safety variables will include serum transaminases routine chemistry parameters hematology and adverse events 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 |
|---|---|---|---|
| The TROPIC Study | None | None | None |