Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007338

Trial Description

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Title

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects With Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D)

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Trial Acronym

TEMPO

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URL of the Trial

[---]*

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Brief Summary in Lay Language

This study is to evaluate the effect of GS-6615 compared to placebo on the overall
occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions
(antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization
therapy-defibrillator (CRT-D).

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007338
  •   2016/03/11
  •   2014/04/02
  •   no
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Secondary IDs

  •   2013-004430-15 
  •   NCT02104583  (ClinicalTrials.gov)
  •   GS-US-356-0101  (Gilead Sciences)
  •   2013-004430-15 
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Health Condition or Problem studied

  •   Ventricular Arrhythmia
  •   I30-I52 -  Other forms of heart disease
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Interventions/Observational Groups

  •   Drug: GS-6615
  •   Drug: Placebo to match GS-6615
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, caregiver, investigator/therapist, assessor
  •   Placebo
  •   Treatment
  •   Parallel
  •   II
  •   [---]*
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Primary Outcome

- Overall occurrence (total number) of appropriate ICD interventions (ATP or shock) through Week 24; time frame: Up to 24 weeks

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Secondary Outcome

- Overall occurrence (total number) of appropriate ICD interventions (ATP or shock) through end of study; time frame: Up to 20 months
- Change in PVC; time frame: Baseline; Week 12; Change in premature ventricular complex (PVC) from baseline will be measured in units of count/48 hours.
- Change in nsVT; time frame: Baseline; Week 12; Change in non-sustained ventricular tachycardia (nsVT) from baseline will be measured in units of number of episodes/48 hours.
- Overall occurrence (total number) of ventricular tachycardia/ventricular fibrillation (treated or untreated) through Week 24; time frame: Up to 24 weeks
- Overall occurrence (total number) of ventricular tachycardia/ventricular fibrillation (treated or untreated) through the end of the study; time frame: Up to 20 months
- Time from randomization to the first occurrence of appropriate ICD interventions (ATP or shock) or cardiovascular (CV) death; time frame: Up to 20 months
- Overall occurrence (total number) of electrical storm through Week 24; time frame: Up to 24 weeks
- Overall occurrence (total number) of electrical storm through the end of study; time frame: Up to 20 months
- Overall occurrence (total number) of inappropriate ICD interventions through Week 24; time frame: Up to 24 weeks
- Overall occurrence (total number) of inappropriate ICD interventions through the end of the study; time frame: Up to 20 months
- Time from randomization to the first occurrence of CV hospitalization, emergency room (ER) visit, or CV death; time frame: Up to 20 months
- Change in left ventricular systolic and diastolic function as assessed by echocardiography; time frame: Weeks 12 and 24

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Countries of Recruitment

  •   United States
  •   Canada
  •   Czech Republic
  •   Denmark
  •   Germany
  •   Hungary
  •   Israel
  •   Netherlands
  •   Poland
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Locations of Recruitment

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Recruitment

  •   [---]*
  •   2014/09/30
  •   270
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- Have an ICD or CRT-D implanted for primary or secondary prevention and at least one
ICD intervention for ventricular tachycardia/ventricular fibrillation (VT/VF) [shock
or ATP] within 60 days prior to screening or a documented VT/VF episode (prior to
implantation) within 60 days prior to screening

- Use of highly effective contraception methods if female of childbearing potential or
sexually active male

- Must be hemodynamically stable

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Exclusion Criteria

- New York Heart Association (NYHA) Class IV heart failure

- Myocardial infarction, unstable angina, coronary artery bypass graft (CABG) surgery
or percutaneous coronary intervention (PCI) within 4 weeks prior to screening or
during the screening period before randomization

- Hemodynamically significant primary obstructive valvular disease

- History of congenital heart disease

- Inherited arrhythmia such as Brugada syndrome. Individuals with long QT syndrome Type
3 (LQT-3) or hypertrophic cardiomyopathy (HCM) may be considered.

- Individuals who are being considered for cardiac transplantation and are on a cardiac
transplant list

- History of seizures or epilepsy

- Cardiac ablation within 3 months prior to screening or planned cardiac ablation
during the study

- Severe renal impairment

- Abnormal liver function tests

- Currently taking Class I and Class III antiarrhythmic drugs; such medications should
be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to
randomization

- Currently taking drugs or products that are strong inhibitors or inducers of CYP3A;
such medications should be discontinued 5 half-lives prior to randomization

- Currently taking ranolazine; Ranolazine should be discontinued at least 7 days prior
to Randomization

- Females who are pregnant or are breastfeeding

- Individuals with a subcutaneous ICD

- Body mass index (BMI) ≥ 36 kg/m^2

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Addresses

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    • Gilead Sciences
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    • Gilead Sciences
    • Ewa Prokopczuk, MD, PhD 
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    •   [---]*
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    • Gilead Study Team 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.