Ignite Creation Date:
2024-05-05 @ 9:28 PM
Last Modification Date:
2024-10-26 @ 10:05 AM
Study NCT ID:
NCT00899977
Status:
TERMINATED
Last Update Posted:
2013-09-13
First Post:
2009-05-08
Brief Title:
TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
Sponsor:
Targacept Inc
Organization:
Targacept Inc
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Sequential Group Pilot Study to Assess Safety Tolerability and Effectiveness of TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A pilot study of subjects with refractory hypertension on 3 concomitant agents with SBP 140 mmHg and a DBP 90 mmHg randomized in a double-blind fashion to receive 4 single escalating doses of study medication in clinic
Detailed Description:
12 subjects with refractory hypertension will be randomized in a double-blind fashion to receive single escalating doses of study medication in-clinic on Day 1 1mg Day 8 2mg Day 15 4mg and Day 22 8mg On each of these 4 days 10 subjects will receive TC-5214 and 2 subjects will receive placebo Placebo treatments will be pooled across the 4 days of single-dose to produce an equivalent reference cohort n 8 for each treatment dose n10 Following the single-dose administration of 8mg in the clinic on Day 22 subjects will continue with two weeks Days 23 - 35 of outpatient self-administration of TC-5214 4mg BID n 6 or matching placebo BID n 6 On Day 36 subjects will return for a final in-clinic dose of either TC-5214 4mg n 6 or placebo n 6 There will be a 1-week follow-up period at the end of the treatment period
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