Trial · NCT02135848
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 67 days | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. |
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to 39 days | Twelve lead ECGs were recorded with the participant lying supine, having rested in this position for at least 5 minutes before each recording. Full 12 lead ECGs were recorded using an ECG device that automatically calculated the heart rate and measured PR, QRS, RR, QT and QT, QT corrected by Bazett's formula (QTcB) and QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant \[NCS\] and clinically significant \[CS\]) ECG findings are presented. |
| Primary | Number of Participants With Vital Signs of Potential Clinical Importance | Up to 39 days | Vital signs included heart rate, systolic and diastolic blood pressure and were performed with the participant in a supine position after the participant had rested for at least 5 minutes. Number of participants with vital signs of potential clinical importance are presented. |
| Primary | Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance | Up to 67 days | Clinical chemistry analyte of potential clinical concern included albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium and bicarbonate. Number of participants with clinical chemistry abnormalities of potential clinical importance are presented. |
| Primary | Number of Participants With Clinical Hematology Abnormalities of Potential Clinical Importance | Up to 67 days | Hematology parameters included platelet count, red blood cell (RBC) count, white blood cell WBC count (absolute), hemoglobin, hematocrit, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils and basophils. Number of participants with clinical hematology abnormalities of potential clinical importance are presented. |
| Secondary | Change From Baseline in Total Number of Contractions to Onset of Claudication | Baseline (Day 1) to Day 39 | At Visit 1 (-21 to -10 days), the participant was introduced to the bilateral heel raise test (BHRT). Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg. Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. The index leg was defined as the leg that met the inclusion symptomatic and hemodynamic criteria (ankle brachial index \[ABI\] ≤ 0.90) with the lowest ABI considered if both legs were affected. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Work Performed to Onset of Claudication | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with peripheral artery disease (PAD) and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to BHRT. Test familiarization consisted of the participant performing heel raises to onset of claudication. BHRT was conducted with an electrogoniometer instrumented on the index leg (leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until participant stopped due to intolerable claudication pain/fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Exercise Time to Onset of Claudication | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Number of Contractions to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Work Performed to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Total Exercise Time to Claudication-limited Maximal Muscle Performance | Baseline (Day 1) to Day 39 | BHRT is a method to assess muscle performance in participants with claudication. Participants with PAD and claudication experience reproducible symptoms of leg pain during walking exercise. The symptom of claudication is due to exercise-induced ischemia of muscles in legs, most commonly in calf muscles. At Visit 1 (-21 to -10 days), the participant was introduced to the BHRT. Test familiarization consisted of the participant performing heel raises to the onset of claudication. The BHRT was conducted with an electrogoniometer instrumented on the index leg (the leg that met the inclusion symptomatic and hemodynamic criteria \[ABI ≤ 0.90\] with the lowest ABI considered if both legs were affected). Successive heel raise repetitions were performed once every other second until the participant stopped due to intolerable claudication pain or fatigue, or other criteria for stopping the test were met. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in the Maximal Distance Covered During a Six-Minute Walk Test | Baseline (Day 1) to Day 39 | The Six-Minute Walk Test was performed by the participant walking at a self-selected pace for 6 minutes through a pre-defined walking course. When the Six-Minute Walk Test and Bilateral Heel Raise Test were conducted at the same study visit, the participant was allowed to rest a minimum of one hour between these tests. Baseline was Day 1. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Erythropoietin Concentration | Baseline (Day 1) to Day 39 | Blood samples for analysis of fasting levels of erythropoietin, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Hemoglobin | Baseline (Day 1) to Day 39 | Blood samples for analysis of fasting levels of hemoglobin was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in Hematocrit | Baseline (Day 1) to Day 39 | Blood samples for analysis of fasting levels of hematocrit was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values. |
| Secondary | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | Baseline (Day 1) to Day 39 | Blood samples for analysis of fasting levels of hsCRP, was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values. |
| 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 | Blood samples for analysis of fasting levels of lipid panel (TC, TG, HDLc and LDLc) was collected up to end of treatment or early termination. Baseline acute was Day 1 and Baseline chronic was Day 21. Change from Baseline was post-Baseline values minus Baseline values. |
| 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) | Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded. |
| 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) | Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded. |
| 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) | Blood samples for pharmacokinetic analysis of GSK1278863 and selected metabolites were collected at the following time points: Visit 2-Baseline acute: pre-dose, 1 hour, 2 hours and 3.5 hours post-dose, Visit 3-post acute, Visit 4-rescreen, Visit 5-Baseline chronic and end of treatment or early termination. The actual date and time of each blood sample collection was recorded. |
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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