A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Prism Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00739193
First received: August 20, 2008
Last updated: October 23, 2008
Last verified: October 2008
  Purpose

The primary objective of this trial is to compare the relative hemodynamic effect of a novel intravenous formulation of amiodarone (PM101), administered as an immediate IV bolus push, with placebo and with the currentlyl available formulation of Amiodarone IV, administered as a 10-minute IV infusion, on systolic arterial pressure.


Condition Intervention Phase
Blood Pressure
Drug: amiodarone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Double Dummy Trial To Determine The Relative Effect Of Pm101 Versus Placebo And Amiodarone IV On Blood Pressure In Subjects With Stable Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Prism Pharmaceuticals:

Primary Outcome Measures:
  • Systolic blood pressure [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: August 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Control
Drug: amiodarone
Experimental: PM101
PM101
Drug: amiodarone
Active Comparator: Amiodarone IV
Amiodarone IV
Drug: amiodarone

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women >18 years of age at Screening, with a diagnosis of stable congestive heart failure
  • NYHA Functional Classification of Heart Failure Class II, III, or IV
  • Documented left ventricular ejection fraction ≤35% within 6 months before Screening, provided that the assessment was not within 4 weeks of a myocardial infarction
  • Outpatient or inpatient
  • On stable doses of medications to treat congestive heart failure (eg, beta-blockers, angiotensin-converting enzyme inhibitor/angiotensin-receptor antagonist, diuretic) for at least 7 days before dosing with trial drug
  • Have a 12-lead electrocardiogram (ECG) at Screening that shows no clinically significant abnormalities of rate, rhythm, or conduction (such as high-grade atrioventricular block, bifascicular or trifascicular block), that would jeopardize the safety or the ability to accurately measure the arterial pressure of the subject, in the opinion of the investigator
  • Able to communicate effectively with the trial personnel
  • Able to undergo study related procedures as required by the protocol
  • Adequately informed of the nature and risks of the trial and give written informed consent prior to undergoing any trial-related procedures
  • Women of childbearing potential must have a negative pregnancy test both at Screening and at check-in to the trial site before receiving trial drug on Day 1 and must be using an effective medically acceptable form of birth control for the duration of the trial (up through the Day 8 follow-up evaluation)

Exclusion Criteria:

  • Known hypersensitivity or allergy to amiodarone, Captisol, Amiodarone IV, or any of its excipients
  • Known hypersensitivity or allergy to iodine or radio-opaque dyes
  • Presence of asthma or other pulmonary disease, thyroid disease (hypo or hyperthyroidism), hepatitis, or other liver disease that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
  • Myocardial infarction within the 30 days before Screening
  • Functioning pacemaker at Screening or on Day 1
  • Amiodarone administration within 7 days before dosing with trial drug
  • Cardiogenic shock, marked sinus bradycardia, or second- or third-degree atrioventricular block
  • Any disease or condition that might compromise trial evaluations or place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
  • Any clinically significantly abnormal laboratory test at Screening or Day 1 that would place the subject at increased risk from treatment with amiodarone, in the opinion of the investigator
  • Women who are pregnant or breastfeeding A-ny subject who has received an investigational drug within 30 days before dosing with trial drug
  • Inability to obtain 3 baseline SAP readings with no more than 5 mm Hg difference among these readings
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prism Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00739193     History of Changes
Other Study ID Numbers: 105
Study First Received: August 20, 2008
Last Updated: October 23, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Prism Pharmaceuticals:
Blood Pressure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Amiodarone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on August 19, 2014