Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00300365
Status:
COMPLETED
Last Update Posted:
2017-07-28
First Post:
2006-03-06
Brief Title:
Pioglitazone vs Placebo in Combination With Niacin Extended Release on Low HDL
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Trial of Pioglitazone and Niacin Extended Release in Non-diabetic Patients With Metabolic Syndrome
Status:
COMPLETED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We will test our primary hypothesis that combining niacin extended release niacin-ER at a daily dosage of up to 20 g with pioglitazone at a daily dosage of 45 mg will result in a 12 greater increase in HDL-C when compared to niacin-ER monotherapy over 12 weeks in non-diabetic patients with the metabolic syndrome see Table 1
Detailed Description:
This is a two-arm parallel double-blind randomized prospective clinical trial The subjects will be asked to provide informed consent and then undergo screening for enrollment criteria at the first visit -5 weeks The subjects who are eligible and provide informed consent will return for Visit 2 baseline data -4 weeks and then begin the unblinded niacin-ER titration Specifically subjects will receive a starting dose of niacin-ER of 500 mg per day which will be increased in 500 mg increments every week up to a dose of 2000 mg per day Subjects will need to tolerate at least 1500 mg per day of niacin-ER in order to remain in the study and be randomized Thus subjects who are unable to tolerate the 2000 mg daily dose of niacin-ER will be taken back to 1500 mg per day for one week and then randomized Subjects who develop prohibitive side effects at doses less than 1500 mg per day will be discontinued from the study All subjects who are able to take the target dose of niacin-ER will continue that dose of niacin-ER and come to the General Clinical Research Center GCRC to be randomized in a 11 fashion to either niacin-ER plus pioglitazone or niacin-ER plus matching placebo for 12 weeks Pioglitazone will be started at 30 mg and then increased to 45 mg at week 6 This entry design is designed to minimize the differences in mean dose of niacin-ER and dropout rate between study groups
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 |
|---|---|---|---|
| Pionir | OTHER | University of Pennsylvania | None |