NCT01403922

To Determine Blood Pressure Interaction Between TC-5214 and Anti-Hypertensive Medications (Calcium Channel Blockers, Beta Blockers, and ACE Inhibitors) in Patients With Chronic Hypertension

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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)

Conditions

• Chronic Hypertension

Interventions

Type	Name	Description
DRUG	TC-5214	Tablet oral bid days 1 to 7
DRUG	TC-5214	Tablet oral bid days 8 to 14

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2011-07-27
• Last updated: 2012-10-02

Locations

4 sites across 3 countries: United States, Germany, United Kingdom