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

This study has been terminated.
(Sponsor's decision to terminate)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01403922
First received: July 26, 2011
Last updated: October 1, 2012
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Chronic Hypertension
Drug: TC-5214
Phase 1

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Part 1: To measure the effect of TC-5214 on sitting blood pressure in patients with chronic hypertension. [ Time Frame: Day 1 through to follow up ] [ Designated as safety issue: Yes ]

    The following assessments will be measured and reported:

    - A change from baseline in blood pressure and pulse rate.


  • 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. [ Time Frame: Day 1 through to follow up ] [ Designated as safety issue: Yes ]

    The following assessments will be measured and reported:

    A change from baseline in blood pressure and pulse rate.



Secondary Outcome Measures:
  • To examine the safety and tolerability of TC-5214. [ Time Frame: Day 1 through to Follow up ] [ Designated as safety issue: Yes ]

    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

  • The concentration of TC-5214 in plasma will be measured. [ Time Frame: Day 1 to day 28 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
TC-5214
Drug: TC-5214
Tablet oral bid days 1 to 7
Experimental: 2
TC-5214 with placebo
Drug: TC-5214
Tablet oral bid days 8 to 14
Experimental: 3
TC-5214 with placebo
Drug: TC-5214
Tablet oral bid days 1 to 7
Experimental: 4
TC-5214
Drug: TC-5214
Tablet oral bid days 8 to 14

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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01403922

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, New Jersey
Research Site
Willingboro, New Jersey, United States
Germany
Research Site
Berlin, Germany
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hans A Eriksson, MD, PhD, MBA AstraZeneca PharmaceuticalsKvarnbergagatan 12, 15185, Sodertalje, Sweden
Principal Investigator: James Ritter, MD,FRCP FFPM Quintiles Drug Research Unit at Guy's HospitalQuintiles Limited6 Newcomen StreetLondon SE1 1YR
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01403922     History of Changes
Other Study ID Numbers: D4130C00010
Study First Received: July 26, 2011
Last Updated: October 1, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration
Germany: German Regulatory Agency

Keywords provided by AstraZeneca:
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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Calcium Channel Blockers
Antihypertensive Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014