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

NCT00739193 | Withdrawn Phase 2

• 1 other identifier: 105
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Blood Pressure

Keywords

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  15 minutes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Control

Drug: amiodarone

PM101

EXPERIMENTAL

PM101

Drug: amiodarone

Amiodarone IV

ACTIVE COMPARATOR

Amiodarone IV

Drug: amiodarone

Interventions

amiodarone DRUG

Amiodarone IV; PM101; Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Prism Pharmaceuticals: lead

MeSH Terms

Interventions

Amiodarone

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 21, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 11, 2017

Record last verified: 2017-09