NCT00899977

TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Targacept Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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 (n=10). 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.

Conditions

• Refractory Hypertension

Interventions

Type	Name	Description
DRUG	Placebo	Matching placebo
DRUG	TC-5214

Timeline

• Start date: 2009-05-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2009-05-12
• Last updated: 2013-09-13

Locations

1 site across 1 country: United States