Clinical TrialID 7175
Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
NCT01873950
Drug-induced Surface ECG Changes
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 7175
- Evidence Id
- 7175
- Core Evidence Id
- 7175
- Source Clinical Trial Id
- 7165
- Herb2 Clinical Trial Id
- HBCT007165
- Nct Id
- NCT01873950
- Title
- Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Drug-induced Surface ECG Changes
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Ranolazine|DRUG: Dofetilide|DRUG: Verapamil|DRUG: Quinidine sulfate|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Crossover
- Intervention Mask
- Double
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult
- Enrollment
- 22
- Outcome Measure
- Placebo, and Baseline-adjusted Changes in PR, QRS, J-Tpeak, Tpeak-Tend and QTc, Compute maximum mean placebo, and baseline-adjusted change for: PR (ms), QRS (ms), J-Tpeak (ms), Tpeak-Tend (ms) and QTc (ms), 24 hours|Placebo, and Baseline-adjusted Changes in Spatial QRS-T Angle, Compute maximum mean placebo, and baseline-adjusted change for: spatial QRS-T angle (degrees), 24 hours|Placebo, and Baseline-adjusted Changes in Ventricular Gradient, Compute maximum mean placebo, and baseline-adjusted change for: ventricular gradient (mV\*ms)., 24 hours
- Sponsor Collaborator
- Food and Drug Administration (FDA)|Spaulding Clinical Research LLC
- Funded By
- FED
- Location
- Other Id
- 13-011D|SCR-002
- Start Date
- 2013-05
- Primary Completion Date
- 2013-07
- Completion Date
- 2014-12
- First Posted
- 2013-06-10
- Results First Posted
- 2015-05-21
- Last Update Posted
- 2018-03-08
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01873950
- Title Cn
- Title En
- Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
- Bilingual Status
- semi_complete