Phase 2 Study of Oral K201 for Prevention of AF Recurrence

NCT01067833 | Terminated Phase 2 DMC

• 1 other identifier: CJO-201
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the safety, efficacy, and tolerability of 3 doses of K201 (oral) administered for up to 28 days in subjects with recent DC cardioversion to sinus rhythm from sustained symptomatic atrial fibrillation (AF duration \>3 days and \<6 months).

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; AF

Outcome Measures

Primary Outcomes (6)

• time to first documented recurrence of symptomatic AF

  28 days

• time to first documented recurrence of symptomatic or asymptomatic AF

  28 days

• proportion of subjects in sinus rhythm

  Day 28

• number of AF beats

  10 days

• time in AF

  10 days

• safety assessments: vital signs, laboratory assays, ECG parameters, physical exams, frequency of adverse events

  42 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo Tablet

Dose 1

EXPERIMENTAL

K201

Drug: K201 Tablet

Dose 2

EXPERIMENTAL

K201

Drug: K201 Tablet

Dose 3

EXPERIMENTAL

K201

Drug: K201 Tablet

Interventions

K201 Tablet DRUG

oral tablet, x28 days

Dose 1; Dose 2; Dose 3

Placebo Tablet DRUG

oral tablet, x28 days

Placebo

Eligibility Criteria

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

You may qualify if:

• Symptomatic AF (sustained \>3 days and \<6 months) and clinically indicated for cardioversion;
• Adequate anticoagulant therapy for cardioversion in accordance with standard practice as recommended by ACC/AHA/ESC guidelines or with local clinical practice;
• Hemodynamically stable (90 mmHg \< systolic blood pressure \< 190 mmHg)at screening and on Day 1;

You may not qualify if:

• Known prolonged QT syndrome or QTc interval of \>0.500 sec at screening; familial long QT syndrome; previous Torsade de Pointes; ventricular fibrillation; or sustained ventricular tachycardia (VT);
• QRS \>0.130 sec;
• Previous episodes of second- or third-degree atrioventricular block;
• Unsuccessful DC cardioversion attempt within 3 months; prior ablation for AF;
• Persistent bradycardia with ventricular rate below 50 beats/min, sick-sinus syndrome or pacemaker (including CRT, AICD);
• Myocardial infarction (MI), cardiac surgery, angioplasty, unstable angina or acute coronary syndrome within 30 days prior to entry into the study;
• NYHA Class III or Class IV heart failure (HF) at screening or admission, or hospitalized for HF in previous 6 months;
• Known concurrent temporary secondary causes of AF;
• Received a Class I or Class III antiarrhythmic agent (including sotalol) within 5 half-lives of randomization or amiodarone or dronedarone within 4 weeks;
• Received treatment with other drugs known to prolong the QT interval within 5 half-lives.

Sponsors & Collaborators

• Sequel Pharmaceuticals, Inc: lead

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

K201 compound

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Chamberlin, MD

  Sequel Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 10, 2010
• First Posted: February 12, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 16, 2011

Record last verified: 2011-05