TC-5214 as Augmentation Therapy in Patients With Refractory Hypertension

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.