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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00899977
Other study ID # TC-5214-23-CRD-002
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received May 8, 2009
Last updated September 3, 2013
Start date May 2009
Est. completion date December 2009

Study information

Verified date September 2013
Source Targacept Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date December 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

1. Refractory hypertension, defined as a SBP of >140mmHg and a DBP > 90mmHg, on stable doses of at least 3 concomitant antihypertensive treatment (which must include a diuretic and an ACEI, ARB or RA) for 8 weeks prior to Screening. All approved antihypertensive treatments are allowed except for alpha-adrenergic blockers, hydralazine, clonidine, guanethidine, guanadrel, and rauwolfia alkaloids.

2. Stable hypertension, as defined by: a. mean SBP on Day -7 that is within 20mmHg of the mean SBP on Day 1, with both mean SBPs > 140mmHg; and b. mean DBP on Day -7 that is within 10mm of the mean DBP on Day 1, with both mean DBPs > 90mmHg.

3. Outpatient with stable housing.

4. Subjects must be able to stay in the clinic for 8 hrs on Day 1, Day 8, Day 15, Day 22, and Day 36.

5. Able to give and to sign informed consent.

Exclusion Criteria:

1. Any unstable medical condition other than hypertension;

2. Stage 3 hypertension (SBP > 180mmHg and/or DBP > 110mmHg);

3. Heart rate > 100 beats per minute;

4. WOCBP who is pregnant or who is planning to become pregnant during the study;

5. History within past year of alcohol or illicit drug abuse;

6. Unable to comply with study procedures in opinion of investigator;

7. Concomitant medications for any medical condition that is uncontrolled for more than 2 weeks prior to study entry;

8. Current use of alpha-adrenergic blocker, hydralazine, clonidine, guanethidine, guanadrel, or rauwolfia alkaloids;

9. History of myocardial infarction or angina pectoris;

10. Current seizure disorder;

11. Renal insufficiency as defined by a serum creatinine > 2.0;

12. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency;

13. History of or concurrent ileus, glaucoma, or urinary retention;

14. Inability of subject to understand and sign the ICF;

15. Known systemic infection (HBV, HCV, HIV, TB);

16. Current use of smoking cessation therapy within 4 weeks of screening;

17. Use of herbal supplements;

18. Clinically significant finding on physical exam;

19. Clinically significant laboratory or ECG abnormality, including QTcF > 460 msec;

20. Participation in another clinical trial in last month;

21. Body Mass Index (BMI) > 35.

22. Body weight < 100 pounds.

23. Site staff or family member of study site staff.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Placebo
Matching placebo
TC-5214


Locations

Country Name City State
United States Piedmont Medical Research Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Targacept Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean difference between TC-5214 and placebo in change at 3 hours from baseline SBP Following dosing, 3 manual seated BP measurements and orthostatic BP measurements will be obtained in an identical fashion, at 30 minutes post-dose and at 1, 2, 3, 4, 5, 6, 7, and 8 hrs post-dose. Yes
Secondary Safety and tolerability of TC-5214 in patients with refractory hypertension and obtain preliminary dose-response estimates Days 1, 8, 15, 22 and 36 Yes
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