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

Chronic Hypertension Clinical Trial

Official 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01403922
• Other study ID #: D4130C00010
• Status: Terminated
• Phase: Phase 1
• First received: July 26, 2011
• Last updated: October 1, 2012
• Start date: August 2011
• Est. completion date: August 2012

Study information

• Verified date: October 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug AdministrationGermany: German Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Chronic Hypertension
• Hypertension

Intervention

Drug:
• TC-5214
Tablet oral bid days 1 to 7
• TC-5214
Tablet oral bid days 8 to 14

Locations

Country	Name	City	State
Germany	Research Site	Berlin
United Kingdom	Research Site	London
United States	Research Site	Overland Park	Kansas
United States	Research Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	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	Day 1 through to Follow up	Yes
Secondary	The concentration of TC-5214 in plasma will be measured.		Day 1 to day 28	Yes