Trial · NCT03415152
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Adherence Rate at the End of the Study (Visit 3) | 6 months | Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period. |
| Secondary | Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) at the End of the Study (Visit 3) | 6 months | The average score for the National questionnaire on therapy compliance for all study duration Visit 1 - Visit 3. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance |
| Secondary | The Percentage of Patients Who Have Chosen Each of the Suggested Reasons for Therapy Termination | 6 months | The percentage of patients (%) who have chosen each of the suggested reason for therapy termination. |
| Secondary | The 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 months | Mean difference of the average score on each of 8 scales of Short Form Survey (SF)-36 quality of life questionnaire at Visit 2 and Visit 3 versus the baseline. 36-Item Short Form Survey (SF-36) taps eight health concepts. Each of 36 items is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively, so that a high score defines a more favorable health state. |
| Secondary | Change of Lipid Profile Parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1) | 3 months, 6 months | Mean difference of lipid profile parameters at Visit 2 and Visit 3 vs. the Baseline (Visit 1\) |
| Secondary | Number of Hospitalizations Due to Cardio-vascular Reasons During 6 Months of the Program | 6 months | Percentage of patients with hospitalizations due to cardiovascular disease |
| Secondary | Number of New Cases of Stenocardia During 6 Months of the Program | 6 months | Percentage of patients with new cases of stenocardia |
| Secondary | Number of Non-fatal Myocardial Infarction Cases During 6 Months of the Program | 6 months | Percentage of patients with non-fatal myocardial infarction cases |
| Secondary | Number of Cases of Cardio-vascular Death During 6 Months of the Program | 6 months | Percentage of patients dead due to cardio-vascular death |
| Secondary | Mean Adherence Rate at Visit 2 | 3 months | Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period. |
| Secondary | Change of Mean Adherence Rate by End of the Study (Visit 3) Versus Visit 2 | 3 months, 6 months | Mean adherence rate is a ratio of the sum of days when the patient took the full prescribed dose of Omacor in the specified period to the number of days in the period. |
| Secondary | The Percentage of Patients With Adherence Rate <0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3 | 3 months, 6 months | The percentage of patients with adherence rate \<0,5, 0,5-0,7, ≥0,8 at Visit 2 and Visit 3 |
| Secondary | Mean Score of National Questionnaire of Treatment Compliance (Edited by Fofanova T.V. et al.) [9] at Visit 1, Visit 2 | 0 months, 3 months | The average score for the National questionnaire on therapy compliance at Visit 1, Visit 2. The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance |
| Secondary | Change 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 Months | The text of the National questionnaire of treatment compliance consists of five statements with four options for choice. The answer corresponding to very high compliance is estimated at 3 points, the answer corresponding to high compliance is estimated at 2 points, medium compliance - at 1 point and low compliance - 0 points. The patient can get a maximum of 15 points, a minimum of 0 points. Higher scores mean higher compliance |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03415152/registered