Trial · NCT00995930
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
NCT00995930, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-03-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients. Trials, record NCT00995930. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00995930
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
- NCT number
- NCT00995930
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 189 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Diabetes Mellitus, Type 2, Atherosclerosis, Prediabetic State
- Interventions
- ACZ885, Placebo
- First posted
- 2009-10-16
- Last updated
- 2015-06-29
- Results first posted
- 2015-03-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events, Serious Adverse Events and Death | 12 months | Participants were monitored for adverse events, serious adverse events and death throughout the study. |
| Primary | Change From Baseline in Aortic Distensibility | baseline, 3 months, 12 months | Two axial, ECG-gated, steady state free precession (SSFP) 'cine' images were acquired during breath-hold to determine aortic distensibility. The first image was obtained at the level of the right pulmonary artery through the ascending and proximal descending aorta and the second through the distal aorta below the diaphragm. Imaging of the aorta also enabled evaluation of the plaque burden and additional vascular function measures. |
| Primary | Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area) | baseline, 3 months, 12 months | For assessment of atherosclerotic plaque burden of the aorta, vessel wall images of the aorta were acquired with an ECG gated double-inversion recovery (black blood) fast spin echo sequence applied breath-holding. Using an oblique sagittal image of the aorta as a pilot, serial axial images were acquired to cover a section of the descending thoracic aorta. The midpoint of the right pulmonary artery in cross section was used as the anatomical reference for the first slice in baseline and follow-up scans. For assessment of the atherosclerotic plaque burden in the carotids, vessel wall images were acquired with an axial ECG gated PD (proton density) weighted black blood sequence. The carotid bifurcation was used as the anatomical reference for all three imaging time points (baseline, 12 weeks, 48 weeks) with axial slice planes acquired below the bifurcation region. The mean values reported here for the carotid are reported for the proximal common carotid region. |
| Secondary | Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error | baseline, 3 months, 12 months | Utilizing the SphygmoCor Device, ECG leads placed at the carotid and femoral arteries provided the measure of the pulse wave at that particular arterial location. The distance between the two vascular beds divided by the pulse wave time shift provided a measure of the pulse wave velocity. |
| Secondary | Change From Baseline in Plaque Composition | baseline, 3 months, 12 months | During the carotid MRI acquisition, in addition to the PD weighted ECG gated double inversion fast spin echo sequences T1 and T2 weighted sequences were acquired. In combination with the PD weighted images, the multi-contrast images were analyzed to determine regions of interest with contrast patterns consistent with the presence of necrotic lipid core, calcification and fibrous tissue in participants who had complex carotid plaque present in the bifurcation region. |
| Secondary | Change From Baseline in Aortic Strain | baseline, 3 months, 12 months | Arterial strain was computed directly from the cine SSFP images and the change in lumen diameters over the cardiac cycle. The value was independent of pulse pressure and is unitless ratio derived from the maximum to minimum lumen diameters diastole and systole, respectively.. |
| Secondary | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | baseline, 3 months, 12 months | Blood samples were collected to analyze hsCRP. |
| Secondary | Change From Baseline in Fasting Plasma Glucose | baseline, 3 months, 12 months | Blood samples were collected to analyze fasting plasma glucose. |
| Secondary | Change From Baseline in Hemoglobin A1c (HbA1c) | baseline, 3 months, 12 months | Blood samples were collected to analyze HbA1c. |
| Secondary | Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT) | baseline, 3 months, 12 months | Blood samples were collected to analyze the 2 hour glucose post OGTT. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Adverse Events, Serious Adverse Events and Death | 12 months | Safety analysis set: The safety analysis set included all randomized participants who received at least one dose of study drug. | Number of participants | NUMBER |
| PRIMARY | Change From Baseline in Aortic Distensibility | baseline, 3 months, 12 months | Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication. | mmHg^-1 | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Plaque Burden (Aortic Vessel Wall Area and Carotid Vessel Wall Area) | baseline, 3 months, 12 months | Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication. | mm^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Pulse Wave Velocity and Pulse Wave Velocity Error | baseline, 3 months, 12 months | Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication. | ms^-1 | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Plaque Composition | baseline, 3 months, 12 months | Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication. | mm^2 | MEAN |
| SECONDARY | Change From Baseline in Aortic Strain | baseline, 3 months, 12 months | Only participants from the imaging analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The imaging analysis set included randomized participants who received at least one dose of study medication. | ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) | baseline, 3 months, 12 months | Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication. | mg/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose | baseline, 3 months, 12 months | Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication. | mmol/L | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin A1c (HbA1c) | baseline, 3 months, 12 months | Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication. | percentage | GEOMETRIC_MEAN |
| SECONDARY | Change From Baseline in 2 Hour Glucose Post Oral Glucose Tolerance Test (OGTT) | baseline, 3 months, 12 months | Only participants from the PD analysis set, who had evaluable data at both baseline and the given post-baseline time point, were included in the analysis for that post baseline time point. The PD analysis set included randomized participants who received at least one dose of study medication. | mmol/L | GEOMETRIC_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group96
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 Adverse Events, Serious Adverse Events and Death | Placebo | Adverse events (serious and non-serious) | 80 | Number of participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | ACZ885 | Adverse events (serious and non-serious) | 77 | Number of participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | Placebo | Serious adverse events | 14 | Number of participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | ACZ885 | Serious adverse events | 25 | Number of participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | Placebo | Deaths | 0 | Number of participants | |
| Number of Participants With Adverse Events, Serious Adverse Events and Death | ACZ885 | Deaths | 1 | Number of participants | |
| Change From Baseline in Aortic Distensibility | Placebo | 3 months, proximal ascending region (n=61,63) | -0.0001 | Standard Error 0.0001 | mmHg^-1 |
| Change From Baseline in Aortic Distensibility | ACZ885 | 3 months, proximal ascending region (n=61,63) | 0.0001 | Standard Error 0.0001 | mmHg^-1 |
| Change From Baseline in Aortic Distensibility | Placebo | 12 months, proximal ascending region (n=56,55) | -0.0001 | Standard Error 0.0001 | mmHg^-1 |
| Change From Baseline in Aortic Distensibility | ACZ885 | 12 months, proximal ascending region (n=56,55) | -0.0001 | Standard Error 0.0001 | mmHg^-1 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 94 | |
| Overall Study | STARTED | ACZ885 | 95 | |
| Overall Study | Safety Analysis Set | Placebo | 94 | |
| Overall Study | Safety Analysis Set | ACZ885 | 95 | |
| Overall Study | Pharmacokinetic (PK) Analysis Set | Placebo | 0 | |
| Overall Study | Pharmacokinetic (PK) Analysis Set | ACZ885 | 95 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | Placebo | 92 | |
| Overall Study | Pharmacodynamic (PD) Analysis Set | ACZ885 | 92 | |
| Overall Study | Imaging Analysis Set | Placebo | 92 | |
| Overall Study | Imaging Analysis Set | ACZ885 | 92 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events136
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 | ACZ885 150mg | 5 | 95 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 6 | 94 | |
| other | Nausea | Gastrointestinal disorders | ACZ885 150mg | 4 | 95 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 7 | 94 | |
| other | Vomiting | Gastrointestinal disorders | ACZ885 150mg | 0 | 95 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 5 | 94 | |
| other | Asthenia | General disorders | ACZ885 150mg | 2 | 95 | |
| other | Asthenia | General disorders | Placebo | 5 | 94 | |
| other | Fatigue | General disorders | ACZ885 150mg | 2 | 95 | |
| other | Fatigue | General disorders | Placebo | 8 | 94 |
1 to 10 of 136Source ClinicalTrials.gov
See all 136 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ACZ885 150mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | ACZ885 150mg | 46 | 95 |
| Total, other adverse events | Placebo | 65 | 94 |
| Total, serious adverse events | ACZ885 150mg | 25 | 95 |
| Total, serious adverse events | Placebo | 14 | 94 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27737744 | DERIVED |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ACZ885 150mg vs Placebo: serious adverse events |
Source 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/NCT00995930
GET https://conductscience.org/api/trials/v1/NCT00995930/results?page=2