TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension

• Status: Terminated
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Targacept Inc.

Criteria

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.