Trial · NCT02135848
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 67 days | Safety population which comprised of all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to 39 days | Safety Population. Only those participants with data available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Signs of Potential Clinical Importance | Up to 39 days | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance | Up to 67 days | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance | Up to 67 days | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Number of Contractions to Onset of Claudication | Baseline (Day 1) to Day 39 | Pharmacodynamic population comprised of all participants who provided pharmacodynamic data, i.e. bilateral heel-raise data or six-minute-walk-test data. Only those participants with data available at the indicated time points were analyzed. | Contractions | MEAN |
| SECONDARY | Change From Baseline in Total Work Performed to Onset of Claudication | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | kilogram-meters | MEAN |
| SECONDARY | Change From Baseline in Total Exercise Time to Onset of Claudication | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Seconds | MEAN |
| SECONDARY | Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Contractions | MEAN |
| SECONDARY | Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | kilogram-meters | MEAN |
| SECONDARY | Change From Baseline in Total Exercise Time to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | seconds | MEAN |
| SECONDARY | Change From Baseline in the Maximal Distance Covered During a Six-Minute Walk Test | Baseline (Day 1) to Day 39 | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Feet | MEAN |
| SECONDARY | Change From Baseline in Erythropoietin Concentration | Baseline (Day 1) to Day 39 | Pharmacodynamic Population. Only those participants available at the specified time points were analyzed. | Units per Liter | MEAN |
| SECONDARY | Change From Baseline in Hemoglobin | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Grams per Liter | MEAN |
| SECONDARY | Change From Baseline in Hematocrit | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Fraction | MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Milligrams/Liter (mg/L) | MEAN |
| SECONDARY | Change From Baseline in Lipids (Total Cholesterol [TC], Triglycerides [TG], High Density Lipoprotein Cholesterol [HDLc] and Low Density Lipoprotein Cholesterol [LDLc]) | Baseline (Day 1) to Day 39 | Pharmacodynamic population. Only those participants available at the specified time points were analyzed. | Millimoles/Liter (MMOL/L) | MEAN |
| SECONDARY | Derived Plasma GSK1278863 Pharmacokinetic Parameter- Maximum Plasma Concentration (Cmax) and Trough Concentration (Ctau) | Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6) | Pharmacokinetic concentration population comprised of all participants from whom a pharmacokinetic sample had been obtained and analyzed. Only those participants available at the specified time points were analyzed. | Nanogram/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Derived Plasma GSK1278863 Pharmacokinetic Parameter -Area Under the Curve (AUC [0-t]) | Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6) | Pharmacokinetic concentration Population. Only those participants available at the specified time points were analyzed. | Nanogram x hour/milliliter (ng*h/mL) | GEOMETRIC_MEAN |
| SECONDARY | Derived Plasma GSK1278863 Pharmacokinetic Parameter - Time to Maximum Plasma Concentration (T-max) and Last Time Point Where the Concentration is Above the Limit of Quantification (T-last) | Visit 2 (Day 1): pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3 (Day 2)-post acute, Visit 4 (Day 16)-rescreen, Visit 5 (Day 23)-Baseline chronic and end of treatment (14 days after Visit 5) or early termination (between Visit 2 and 6) | Pharmacokinetic concentration population. Only those participants available at the specified time points were analyzed. | Hour | MEDIAN |
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
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