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

NCT ID: NCT01403922

Last Updated: 2012-10-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-08-31

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).

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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

1

TC-5214

Group Type: EXPERIMENTAL

TC-5214

Intervention Type: DRUG

Tablet oral bid days 1 to 7

2

TC-5214 with placebo

Group Type: EXPERIMENTAL

TC-5214

Intervention Type: DRUG

Tablet oral bid days 8 to 14

3

TC-5214 with placebo

Group Type: EXPERIMENTAL

TC-5214

Intervention Type: DRUG

Tablet oral bid days 1 to 7

4

TC-5214

Group Type: EXPERIMENTAL

TC-5214

Intervention Type: DRUG

Tablet oral bid days 8 to 14

Interventions

TC-5214

Tablet oral bid days 1 to 7

Intervention Type: DRUG

TC-5214

Tablet oral bid days 8 to 14

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans A Eriksson, MD, PhD, MBA

Role: STUDY_DIRECTOR

AstraZeneca PharmaceuticalsKvarnbergagatan 12, 15185, Sodertalje, Sweden

James Ritter, MD,FRCP FFPM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Research Site

Overland Park, Kansas, United States

Research Site

Willingboro, New Jersey, United States

Research Site

Berlin, , Germany

Research Site

London, , United Kingdom

Countries

United States; Germany; United Kingdom

Other Identifiers

D4130C00010

Identifier Type: -

Identifier Source: org_study_id