This is a two part study. Part 1 will determine determine if administration of TC-5214 has an effect on sitting blood pressure in patients with chronic hypertension. Part 2 will determine any possible interactions between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors).
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
80
Research Site
Overland Park, Kansas, United States
Research Site
Willingboro, New Jersey, United States
Research Site
Berlin, Germany
Research Site
London, United Kingdom
Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension.
The following assessments will be measured and reported: \- A change from baseline in blood pressure and pulse rate.
Time frame: Day 1 through to follow up
Part 2: To measure the effect of TC-5214 combined with treatment with the common classes of anti-hypertensive medication (calcium channel blockers, beta blockers, angiotensin converting enzyme inhibitors) on sitting blood pressure.
The following assessments will be measured and reported: A change from baseline in blood pressure and pulse rate.
Time frame: Day 1 through to follow up
To examine the safety and tolerability of TC-5214.
The following assessments will be measured and reported: * The number of particpants with adverse events * A change from baseline in blood pressure and pulse rate * A change from baseline in laboratory assessments * A change from baseline in vital signs * A change from baseline in electrocardiogram (ECG) * A change from baseline in physical examination
Time frame: Day 1 through to Follow up
The concentration of TC-5214 in plasma will be measured.
Time frame: Day 1 to day 28
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