Trial · NCT01218204
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
NCT01218204, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-11-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin. Trials, record NCT01218204. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218204
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Administering Multiple Oral Doses of GSK1292263 Alone and With Atorvastatin
- NCT number
- NCT01218204
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 287 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Dyslipidaemias, Dyslipidemias
- Interventions
- 10mg atorvastatin, 80mg atorvastatin, GSK1292263 Placebo, 100mg GSK1292263, 300mg GSK1292263, 800mg GSK1292263, 10mg ezetimibe, Washout
- First posted
- 2010-10-11
- Last updated
- 2019-07-16
- Results first posted
- 2017-11-08
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A | Up to Day 26 | An AE is defined as any untoward medical occurrence in a 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. An SAE is defined as 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 an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury. |
| Primary | Number of Participants With Any AEs and SAEs- Part B (Washout) | Up to Day 28 | An AE is defined as any untoward medical occurrence in a 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. An SAE is defined as 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 an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury. |
| Primary | Number of Participants With Any AEs and SAEs- Part B (Run-in) | Up to Day 28 | An AE is defined as any untoward medical occurrence in a 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. An SAE is defined as 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 an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury. |
| Primary | Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm) | Up to Day 26 | An AE is defined as any untoward medical occurrence in a 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. An SAE is defined as 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 an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury. |
| Primary | Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A | Up to Day 26 | Single ECGs were taken after admission on Day -1 and at Follow-up (up to Day 26). On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No value found to be abnormal clinically significant in Part A of the study. |
| Primary | Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout) | Up to Day 28 | ECGs were taken at Screening, and on Day1 and Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. |
| Primary | Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in) | Day 28 | ECGs were taken on Day 28. Single assessments were made. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. No data found to be abnormal clinically significant in run-in phase. |
| Primary | Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm) | Up to Day 26 | Single ECGs were taken after admission on Day -2, and pre-breakfast on Days -1, 4, 10, and at Follow-up. On Days 1, 7, and 14 single ECGS were taken pre-breakfast (fasting) and at 1, 3, 6, 8, 14 and 24 hours post-dose. ECGs were taken in supine position. Additional ECGs were taken at the discretion of the investigator as needed based on symptoms or ECG findings. The data was found to be abnormal clinically significant in treatment phase. |
| Primary | Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A | Up to Day 26 | Assessment of vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate was performed after admission on Day -1 and at Follow-up. On Days 1, 7 and 14, they were taken at pre-dose, 1, 3, 6, 8, 14 and 24 hours after the morning dose. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low. |
| Primary | Number of Participants With Vital Signs of PCI- Part B (Washout) | Up to day 28 | Assessment of vital signs including SBP, DBP heart rate was performed at Screening, on Days 1, 14 and 28 in the morning. At each time point, assessment was performed after resting in a supine or semi-supine position for at least 10 minutes. Data for only those parameters are presented for which findings are of PCI either high or low. |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A | Up to Day 26 | Safety Population consisted of all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any AEs and SAEs- Part B (Washout) | Up to Day 28 | All subject Population consisted of all participants who received at least one dose of study medication. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any AEs and SAEs- Part B (Run-in) | Up to Day 28 | All subject Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any AEs and SAEs- Part B (Pooled Treatment Arm) | Up to Day 26 | All subject Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A | Up to Day 26 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Washout) | Up to Day 28 | All subject Population. Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in) | Day 28 | All subjects Population. Only those participants present during Run in/Day 28 were evaluated/included. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Pooled Treatment Arm) | Up to Day 26 | All subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Signs of Potential Clinical Importance (PCI)- Part A | Up to Day 26 | Safety Population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Vital Signs of PCI- Part B (Washout) | Up to day 28 | All subjects Population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group673
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A | 80 mg Atorvastatin + 800 mg GSK1292263 | Any AE | 0 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A | 800 mg GSK1292263 | Any AE | 2 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A | 80 mg Atorvastatin + 800 mg GSK1292263 | Any SAE | 0 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)- Part A | 800 mg GSK1292263 | Any SAE | 0 | Participants | |
| Number of Participants With Any AEs and SAEs- Part B (Washout) | Pre-treatment | Any AE | 14 | Participants | |
| Number of Participants With Any AEs and SAEs- Part B (Washout) | Washout | Any AE | 37 | Participants | |
| Number of Participants With Any AEs and SAEs- Part B (Washout) | Pre-treatment | Any SAE | 0 | Participants | |
| Number of Participants With Any AEs and SAEs- Part B (Washout) | Washout | Any SAE | 0 | Participants | |
| Number of Participants With Any AEs and SAEs- Part B (Run-in) | Atorvastatin 10 mg | Any AE | 19 | Participants | |
| Number of Participants With Any AEs and SAEs- Part B (Run-in) | Atorvastatin 80 mg | Any AE | 8 | Participants |
1 to 10 of 673Source ClinicalTrials.gov
See all 673 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A | 6 | |
| Part A | STARTED | Part B Washout | 0 | |
| Part A | STARTED | Part B Run-in | 0 | |
| Part A | STARTED | Part B Pooled Treatment Arm | 0 | |
| Part A | COMPLETED | Part A | 6 | |
| Part A | COMPLETED | Part B Washout | 0 | |
| Part A | COMPLETED | Part B Run-in | 0 | |
| Part A | COMPLETED | Part B Pooled Treatment Arm | 0 | |
| Part A | NOT COMPLETED | Part A | 0 | |
| Part A | NOT COMPLETED | Part B Washout | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events1,598
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | 80 mg Atorvastatin + 800 mg GSK1292263 (Part A) | 0 | 4 | |
| other | Diarrhoea | Gastrointestinal disorders | 800 mg GSK1292263 (Part A) | 1 | 2 | |
| other | Diarrhoea | Gastrointestinal disorders | Pre-treatment (Part B) | 0 | 281 | |
| other | Diarrhoea | Gastrointestinal disorders | Washout (Part B) | 1 | 281 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 10 mg (Part B Run-in) | 0 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 80 mg (Part B Run-in) | 0 | 27 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 10 mg + GSK1292263 100 mg (Part B Treatment) | 0 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 10 mg + GSK1292263 300 mg (Part B Treatment) | 1 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 10 mg + GSK1292263 800 mg (Part B Treatment) | 0 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | Atorvastatin 10 mg + Placebo (Part B Treatment) | 0 | 12 |
1 to 10 of 1,598Source ClinicalTrials.gov
See all 1,598 adverse eventsAdverse event totals51
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 80 mg Atorvastatin + 800 mg GSK1292263 (Part A) | 0 | 4 |
| Total, all-cause mortality | 800 mg GSK1292263 (Part A) | 0 | 2 |
| Total, all-cause mortality | Pre-treatment (Part B) | 0 | 281 |
| Total, all-cause mortality | Washout (Part B) | 0 | 281 |
| Total, all-cause mortality | Atorvastatin 10 mg (Part B Run-in) | 0 | 62 |
| Total, all-cause mortality | Atorvastatin 80 mg (Part B Run-in) | 0 | 27 |
| Total, all-cause mortality | Atorvastatin 10 mg + GSK1292263 100 mg (Part B Treatment) | 0 | 11 |
| Total, all-cause mortality | Atorvastatin 10 mg + GSK1292263 300 mg (Part B Treatment) | 0 | 11 |
| Total, all-cause mortality | Atorvastatin 10 mg + GSK1292263 800 mg (Part B Treatment) | 0 | 11 |
| Total, all-cause mortality | Atorvastatin 10 mg + Placebo (Part B Treatment) | 0 | 12 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Atorvastatin 10 mg vs Atorvastatin 80 mg: Number of Participants With Abnormal Clinically Significant ECG Findings- Part B (Run-in) | Trial comparisons |
| Atorvastatin 80 mg + GSK1292263 800 mg vs GSK1292263 800 mg: Number of Participants With Abnormal- Clinically Significant Electrocardiogram (ECG) Findings- Part A | Trial comparisons |
| Atorvastatin 80 mg + GSK1292263 800 mg vs GSK1292263 800 mg: Number of Participants With Abnormal Clinical Chemistry Value of PCI- Part A | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01218204
GET https://conductscience.org/api/trials/v1/NCT01218204/registered?page=2