Trial · NCT01154036
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase I) | Baseline and Week 6 (end of Phase I ) | LDL-C levels measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG≥350 mg/dL (3.95 mmol/L). |
| Secondary | Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) (Phase II). | Baseline (Week 6) and Week 12 | LDL-C levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12). Baseline was defined as the average of the values at Visits 5 and 6. LDL-C was calculated using the Friedewald method when triglyceride (TG)\<350 mg/dL (3.95 mmol/L) and beta quantification ultracentrifugation when TG ≥350 mg/dL (3.95 mmol/L). |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase I) | Week 6 (End of Phase I) | |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 100 mg/dL (Phase II) | Week 12 (End of Phase II) | |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase I) | Week 6 (End of Phase I) | |
| Secondary | Percentage of Participants That Reach Target LDL-C Level of < 70 mg/dL (Phase II) | Week 12 (end of Phase II) | |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) (Phase I) | Baseline and Week 6 (end of Phase I) | TC measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in Total Cholesterol (TC) (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | TC levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
| Secondary | Percent Change From Baseline in Triglycerides (TG) (Phase I) | Baseline and Week 6 (end of Phase I) | TG measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. |
| Secondary | Percent Change From Baseline in Triglycerides (TG) (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | TG levels measured at Baseline (Week 6: end of Phase I) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. Baseline and post-baseline measurements were log-transformed in the response vector, with fixed effects for treatment, time and the interaction of time by treatment. |
| Secondary | Percent Change From Baseline in High-density Lipoprotein-Cholesterol (HDL-C) (Phase I) | Baseline and Week 6 (end of Phase I) | HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in HDL-C (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | HDL-C levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
| Secondary | Percent Change From Baseline in Apolipoprotein B (Apo B) (Phase I) | Baseline and Week 6 (end of Phase I) | Apo-B measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in Apo B (Phase II) | Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) | Apo-B levels measured at Baseline (Week 6; end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
| Secondary | Percent Change From Baseline in Apolipoprotein A-I (Apo A-I) (Phase I) | Baseline and Week 6 (end of Phase I) | Apo-A-I measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in Apo A-I (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | Apo-A-I levels measured at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
| Secondary | Percent Change From Baseline in Non-HDL-C (Phase I) | Baseline and Week 6 (end of Phase I) | Non-HDL-C measured at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in Non-HDL-C (Phase II) | Baseline (Week 6; end of Phase I) and Week 12 (end of Phase II) | Non-HDL-C levels calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
| Secondary | Percent Change From Baseline in TC/HDL-C Ratio (Phase I) | Baseline and Week 6 (end of Phase I) | TC/HDL-C ratio calculated at Baseline and after 6 weeks of treatment (Week 6; end of Phase I). Baseline was defined as the average value of the measurements taken at Visits 3 and 4 |
| Secondary | Percent Change From Baseline in TC/HDL-C Ratio (Phase II) | Baseline (Week 6; end of Phase 1) and Week 12 (end of Phase II) | TC/HDL-C Ratio calculated at Baseline (end of Phase 1) and after 6 weeks of study drug administration (Week 12; end of Phase II). Baseline was defined as the average of the values at Visits 5 and 6. |
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.
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GET https://conductscience.org/api/trials/v1/NCT01154036/registered