|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsored by: |
Sequel Pharmaceuticals, Inc |
|---|---|
| Information provided by: | Sequel Pharmaceuticals, Inc |
| ClinicalTrials.gov Identifier: | NCT00626652 |
Purpose
To evaluate the effects of K201 on sinus rhythm restoration, symptom score, various cardiovascular parameters, and safety.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation |
Drug: K201 Injection |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Effects of K201 Injection, 2 mg/mL on the Restoration of Sinus Rhythm in Subjects Who Are in Atrial Fibrillation |
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: K201 Injection
single intravenous infusion, Dose 1, 2, 3, 4, 5, 6, 7, 8 or 9 or placebo (saline) or single oral capsule Dose A or placebo capsule
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Howard C Dittrich, MD | 858.405.1429 | HDittrich@SequelPharma.com |
| Contact: Paul Chamberlin, MD | 858.523.4515 | PChamberlin@SequelPharma.com |
| Israel | |
| Recruiting | |
| Ashkelon, Israel | |
| Recruiting | |
| Holon, Israel | |
| Recruiting | |
| Jerusalem, Israel | |
| Recruiting | |
| Nazareth, Israel | |
| Recruiting | |
| Safed, Israel | |
| Recruiting | |
| Haifa, Israel | |
| Recruiting | |
| Beer Sheva, Israel | |
| Russian Federation | |
| Recruiting | |
| Moscow, Russian Federation | |
| Recruiting | |
| St Petersburg, Russian Federation | |
| Principal Investigator: | Sergey Pavlovich Golitsyn, Prof. | Russian Cardiologic Scientific and Manufacturing Complex of Roszdrav, Institute of Cardiology n.a. A.L.Myasnikov, Department of clinical electrophysiology |
| Principal Investigator: | Amos Katz, Prof. | Barzilai Medical Center |
More Information
| Responsible Party: | Sequel Pharmaceuticals ( Howard C. Dittrich, MD; Chief Medical Officer ) |
| Study ID Numbers: | CJI-201 |
| Study First Received: | February 18, 2008 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00626652 History of Changes |
| Health Authority: | Israel: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation |
|
Heart Diseases Atrial Fibrillation Arrhythmias, Cardiac |
|
Pathologic Processes Heart Diseases Cardiovascular Diseases Atrial Fibrillation Arrhythmias, Cardiac |