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Trial · NCT03415152

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMean Adherence Rate at the End of the Study (Visit 3)6 monthsPopulation of patients registered in electronic system and reported Omacor administrationproportion of daysMEAN
SECONDARYMean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3)6 monthsPopulation of patients attended at Visit 3 (month 6)score on a scaleMEAN
SECONDARYThe Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination6 monthspercentage of participantsNUMBER
SECONDARYThe Average Score on Each of 8 Scales of Short Form Survey (SF)-36 Quality of Life Questionnaire at Visit 2 and Visit 3 vs. the Baseline (Visit 1)3 months, 6 monthsPopulation of patients registered in electronic system and reported Omacor administrationscore on a scaleMEAN
SECONDARYChange of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1)3 months, 6 monthsPer protocol population: patients who attended at least one follow-up visit.mmol/LMEAN
SECONDARYNumber of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program6 monthspercentage of participantsNUMBER
SECONDARYNumber of New Cases of Stenocardia During 6 Months of the Program6 monthspercentage of participantsNUMBER
SECONDARYNumber of Non-fatal Myocardial Infarction Cases During 6 Months of the Program6 monthspercentage of participantsNUMBER
SECONDARYNumber of Cases of Cardio-vascular Death During 6 Months of the Program6 monthspercentage of participantsNUMBER
SECONDARYMean Adherence Rate at Visit 23 monthsPopulation of patients registered in electronic system and reported Omacor administrationproportion of daysMEAN
SECONDARYChange of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 23 months, 6 monthsPopulation of patients registered in electronic system and reported Omacor administrationproportion of daysMEAN
SECONDARYThe Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 33 months, 6 monthsPopulation of patients registered in electronic system and reported Omacor administrationpercentage of participantsNUMBER
SECONDARYMean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 20 months, 3 monthsPer protocol population: patients who attended at least one follow-up visitscore on a scaleMEAN
SECONDARYChange of Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 2 and Visit 3 Versus Baseline (Visit 1)Baseline, 3 Months, 6 MonthsPer protocol population: patients who attended at least one follow-up visitscore on a scaleMEAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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