Trial · NCT00490568
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
NCT00490568, Phase 3, Terminated, GlaxoSmithKline; results first posted 2017-11-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers. Trials, record NCT00490568. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00490568
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
- NCT number
- NCT00490568
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,461 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Alzheimer's Disease
- Interventions
- Rosiglitazone XR
- First posted
- 2007-06-22
- Last updated
- 2017-11-13
- Results first posted
- 2017-11-13
Source ClinicalTrials.gov
Registered outcomes17
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 Severity of AEs | Up to 76 Weeks | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The severity of the AE'S was categorized as mild, moderate and severe. Number of participants reporting AEs during the on treatment phase of the study. |
| Secondary | Number Participants With Serious Adverse Events (SAEs) and Deaths | Up to 76 Weeks | A SAE is defined as any untoward medical occurrence that, at any dose results in death, is a life-threatening condition, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or a congenital anomaly or birth defect. Number of participants with SAEs and deaths were reported for treatment duration of the study. |
| Secondary | Number of Participants With Adverse Event of Oedema | Up to 76 Weeks | Oedema was considered as adverse event of special interest (AESI). The process for AESI selection was based on RSG's pharmacologic class and relevant AEs potentially associated with RSG. The number of participants and their percentage for the adverse event of the various types of oedema were reported. |
| Secondary | Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to 70 Weeks (including follow up) | Vital signs SBP and DBP were measured at each visit. All measurements were made on the participant non-dominant arm supported at heart level, using the same cuff size and same equipment. Blood pressure was measured once, after the participant sat quietly for at least 5 minutes. DBP was measured at the disappearance of Korotkoff sounds (Phase V). If the participant was a smoker or used tobacco products, a period of 30 minutes without tobacco was allowed before taking these measurements. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the blood pressure value recorded at specified visit minus the Baseline value. |
| Secondary | Change From Baseline in Vital Sign Heart Rate (HR) | Up to 70 Weeks (including follow up) | Vital sign HR was measured at each visit. HR was measured once, after the participant sat quietly for at least 5 minutes. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the HR at specified visit minus the Baseline value. |
| Secondary | Change From Baseline in Vital Sign Body Weight (BW) | Up to 70 Weeks (including follow up) | BW was measured at all visits, without shoes and wearing light clothing. Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the body weight at specified visit minus the Baseline value. |
| Secondary | Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides | Up to 82 Weeks (including follow up) | The clinical chemistry data included non-fasting measures of lipid metabolism (TC,HDL,LDL,triglycerides). Baseline for the open-label study was the latest assessment from Week 48 of parent studies to the first dose of open-label medication. Change from Baseline was measured as the lipids (TC,HDL,LDL,triglycerides) value recorded at specified visit minus the Baseline value. |
| Secondary | Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) | Up to 70 Weeks (including follow up) | The frequency of participant vital sign sitting blood pressure was obtained to check if the values lie outside of a pre-determined reference range (RR) for SBP 90-140 mmHg, DBP 50-90 mmHg or have a change from Baseline of PCC for SBP increase from Baseline (IFB) \>=40, decrease from Baseline (DFB) \>= 30 for and for DBP (IFB) \>= 30 ,DFB \>= 20. The number of participants with values of PCC at any time on treatment (ATOT) and follow up were reported. |
| Secondary | Number of Participants With HR Values of PCC ATOT | Up to 70 Weeks (including follow up) | HR was measured once, after the participant sat quietly for at least 5 minutes. The frequency of participant vital sign heart rate was obtained to check if the values lie outside of a pre-determined reference range (RR) 50-100 bpm or have a change from Baseline of PCC IFB \>=30 and DFB \>=30. The number of participants with values of PCC including follow up were reported. |
| Secondary | Number of Participants With BW Values of PCC ATOT | Up to 70 Weeks (including follow up) | The frequency of participant vital sign weight was obtained to check if the values have CFB of PCC IFB \>=7 percent. With the exception of Week 4, when participants were first titrated to the 8mg RSG XR dose, at every time point in the study where weight was measured the percentage of participants experienced an increase in BW of PCC was approximately 2 times greater than the percentage of participants experiencing an decrease in BW of PCC DFB \>=7 percent. The number of participants with values of PCC including follow up were reported. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 Severity of AEs | Up to 76 Weeks | All Subjects (Full population), comprised of all participants who took at least one dose of open-label study medication. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number Participants With Serious Adverse Events (SAEs) and Deaths | Up to 76 Weeks | All subject (Full population) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Event of Oedema | Up to 76 Weeks | All subject (Full population) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Vital Sign Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to 70 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | millimeters of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Vital Sign Heart Rate (HR) | Up to 70 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | beats per minute (bpm) | MEAN |
| SECONDARY | Change From Baseline in Vital Sign Body Weight (BW) | Up to 70 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | kg | MEAN |
| SECONDARY | Change From Baseline in Non-fasting Measures of Lipid Metabolism Namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides | Up to 82 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | millimole per litre (mmol/l) | MEAN |
| SECONDARY | Number of Participants With SBP and DBP Values of Potential Clinical Concern (PCC) | Up to 70 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HR Values of PCC ATOT | Up to 70 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With BW Values of PCC ATOT | Up to 70 Weeks (including follow up) | All subject (Full population). Only those participants available at the specified time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group228
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 Severity of AEs | RSG XR | Any AE | 724 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Severity of AEs | RSG XR | Mild AE | 345 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Severity of AEs | RSG XR | Moderate AE | 289 | Participants | |
| Number of Participants With Any Adverse Events (AEs) and Severity of AEs | RSG XR | Severe AE | 88 | Participants | |
| Number Participants With Serious Adverse Events (SAEs) and Deaths | RSG XR | Any SAE | 126 | Participants | |
| Number Participants With Serious Adverse Events (SAEs) and Deaths | RSG XR | Deaths | 20 | Participants | |
| Number of Participants With Adverse Event of Oedema | RSG XR | Oedema peripheral | 130 | Participants | |
| Number of Participants With Adverse Event of Oedema | RSG XR | Face oedema | 8 | Participants | |
| Number of Participants With Adverse Event of Oedema | RSG XR | Pitting oedema | 5 | Participants | |
| Number of Participants With Adverse Event of Oedema | RSG XR | Oedema | 3 | Participants |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RSG XR | 1,461 | |
| Overall Study | COMPLETED | RSG XR | 97 | |
| Overall Study | NOT COMPLETED | RSG XR | 1,364 |
Source ClinicalTrials.gov
Adverse events104
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 | Oedema peripheral | General disorders | RSG XR | 130 | 1,461 | |
| serious | Fall | Injury, poisoning and procedural complications | RSG XR | 4 | 1,461 | |
| serious | Femur fracture | Injury, poisoning and procedural complications | RSG XR | 3 | 1,461 | |
| serious | Humerus fracture | Injury, poisoning and procedural complications | RSG XR | 2 | 1,461 | |
| serious | Skin laceration | Injury, poisoning and procedural complications | RSG XR | 2 | 1,461 | |
| serious | Spinal compression fracture | Injury, poisoning and procedural complications | RSG XR | 2 | 1,461 | |
| serious | Drug toxicity | Injury, poisoning and procedural complications | RSG XR | 1 | 1,461 | |
| serious | Femoral neck fracture | Injury, poisoning and procedural complications | RSG XR | 1 | 1,461 | |
| serious | Fracture | Injury, poisoning and procedural complications | RSG XR | 1 | 1,461 | |
| serious | Head injury | Injury, poisoning and procedural complications | RSG XR | 1 | 1,461 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RSG XR | 20 | 1,461 |
| Total, other adverse events | RSG XR | 130 | 1,461 |
| Total, serious adverse events | RSG XR | 126 | 1,461 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21592048 | BACKGROUND |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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
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