To investigate interaction of TC-5214 with antihypertensive medication

• Research type

  Research Study

• Full title

  A Phase I Randomised, Placebo-Controlled, Double-Blind Study in Hypertensive Patients of the Blood Pressure Interaction between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors)

• IRAS ID

  84543

• Contact name

  James Ritter

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-002244-27

• Research summary

  Mecamylamine was licensed for the treatment high blood pressure. It is a mixture of two closely related molecules ("isomers"). The study drug, TC-5214, is the active isomer and may be antidepressant in lower doses than were used to treat chronic hypertension patients (high blood pressure). The study drug TC-5214 is being developed by AstraZeneca (the Sponsor, a pharmaceutical company). This study is being carried out on behalf of the sponsor by Quintiles Drug Research Unit at Guy??s Hospital. It is possible that chronic hypertension patients receiving TC-5214 may experience a greater lowering of their blood pressure than healthy volunteers. Patients with chronic hypertension treated with TC-5214 may have blood pressure lowering drugs prescribed. The effects of blood pressure lowering medications may be more pronounced in patients receiving TC-5214. The purpose of this study is to study possible blood pressure effects in chronic hypertension patients, between TC-5214 and blood pressure lowering medications. The study will be conducted in 2 parts: Part 1: to determine if treatment with TC-5214 twice daily has an effect on blood pressure in patients with chronic hypertension who have stopped their medicines. Part 2 is to determine if treatment with TC-5214 affects blood pressures of chronic hypertension patients who are still taking their medications. The blood pressure medicines being studied are called ??calcium channel blockers?, ??beta blockers? and angiotensin converting enzyme inhibitors? (also called ACEI). The TC-5214 may have a greater blood pressure lowering effect when combined with such high blood pressure medications. Approximately 80 patients with chronic hypertension will take part. The study will be conducted in other 4 centres as well as at Quintiles Drug Research Unit at Guy's: 1 in Germany and 3 in the USA.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  11/LO/1078

• Date of REC Opinion

  4 Nov 2011

• REC opinion

  Further Information Favourable Opinion