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

NCT01403922 | Terminated Phase 1

• 1 other identifier: D4130C00010
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 4

Brief 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).

Conditions

Chronic Hypertension

Keywords

Phase I, Randomised, Placebo-Controlled, Double-Blind,Hypertensive Patients, Blood Pressure, Calcium Channel Blockers, Beta Blockers, ACE Inhibitors; Scientific terminology: To determine if treatment with TC5214 alone or in combination with Anti-Hypertensive Medications has an effect on sitting blood pressure; Laymen terminology: Hypertension

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Day 1 through to follow up

Secondary Outcomes (2)

• To examine the safety and tolerability of TC-5214.

  Day 1 through to Follow up

• The concentration of TC-5214 in plasma will be measured.

  Day 1 to day 28

Study Arms (4)

1

EXPERIMENTAL

TC-5214

Drug: TC-5214

2

EXPERIMENTAL

TC-5214 with placebo

Drug: TC-5214

3

EXPERIMENTAL

TC-5214 with placebo

Drug: TC-5214

4

EXPERIMENTAL

TC-5214

Drug: TC-5214

Interventions

TC-5214 DRUG

Tablet oral bid days 1 to 7

1; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent prior to any study specific procedures
• Male or female patients with chronic, stable hypertension treated for at least 1 month before screening with a calcium channel blocker, a beta blocker, or an ACE inhibitor, either as the only anti-hypertensive medication or concurrently with a diuretic. The patients should have no change in their current anti hypertensive treatment for at least 1 month before dosing
• Patients in Part 1 should have an SBP of ≤140 mmHg at screening and ≤160 mmHg at Visit 1a and pre-dose on Day 1
• Patients in Part 2 should have an SBP of ≤160 mmHg at screening Visit 1 and pre dose on Day 1. Systolic blood pressure and DBP should not vary by more than 8 mmHg and 5 mmHg, respectively, in the pre-dose period (screening, Visit 1a, and pre-dose on Day 1)
• Age 18 to 65 years (inclusive)

You may not qualify if:

• Other than having chronic hypertension, the history of any clinically significant medical, neurologic, or psychiatric disease or disorder which, in the opinion of the Investigator and/or the Sponsor, may either put the patient at risk because of participation in the study or influence the results, or the patient's ability to participate in the study. Patients with dyslipidaemia (diet controlled or treated with a statin) and/or metabolic syndrome (diet controlled or treated with metformin) may be entered into the study
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
• Patients with a pre-treatment SBP (if known) of \>180 mmHg or a history of accelerated or malignant hypertension based on grade III (hypertensive haemorrhages and/or cotton wool spots) or grade IV (hypertensive papilloedema) retinopathy at any time
• History or presence of gastrointestinal (including irritable bowel disease), hepatic, or renal disease (creatinine clearance of ≤50 mL/minute calculated using the Cockcroft Gault equation) or any other condition known to interfere with the ADME of the investigational product.
• Patients with a history of surgery on the gastrointestinal tract (not including appendectomy or cholecystectomy) should also be excluded
• Any significant ECG abnormality including QTcF prolongation (\>450 ms) or significant arrhythmias, or junctional rhythms

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Overland Park, Kansas, United States

Location

Research Site

Willingboro, New Jersey, United States

Location

Research Site

Berlin, Germany

Location

Research Site

London, United Kingdom

Location

Study Officials

• Hans A Eriksson, MD, PhD, MBA

  AstraZeneca PharmaceuticalsKvarnbergagatan 12, 15185, Sodertalje, Sweden

  STUDY DIRECTOR

• James Ritter, MD,FRCP FFPM

  Quintiles Drug Research Unit at Guy's HospitalQuintiles Limited6 Newcomen StreetLondon SE1 1YR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: August 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: October 2, 2012

Record last verified: 2012-10

Locations

DE (1); GB (1); US (2)