Trial · NCT03574597
Outcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants From Time of Randomization to First Occurrence of a Composite Outcome Measure Consisting of: Cardiovascular (CV) Death, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to CV Death | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of a Composite Heart Failure (HF) Outcome Measure Consisting of: HF Hospitalisation, Urgent HF Visit or CV Death | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to All-cause Death | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of an Expanded Composite CV Outcome Measure Consisting of: CV Death, Non-fatal MI, Non-fatal Stroke, Coronary Revascularisation or Unstable Angina Pectoris (UAP) Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of a Composite Outcome Measure Consisting of: All-cause Death, Non-fatal MI, or Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Non-fatal MI | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Non-fatal Stroke | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Coronary Revascularisation | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of UAP Requiring Hospitalisation | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of HF Requiring Hospitalisation or Urgent HF Visit | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of Glycosylated Haemoglobin (HbA1c) Greater Than Equals to (≥) 48 Millimole Per Mole (mmol/Mol) (6.5 Percentage [%]) | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c less than (\<) 48 mmol/mol (6.5%) at screening. Participants with ≥ 48 mmol/mol (6.5%) at screening were excluded from this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to First Occurrence of a 5-component Composite Nephropathy Outcome Measure | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants From Time of Randomisation to HbA1c ≥ 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c <39 mmol/Mol [5.7%]) | From randomisation (week 0) up to 240 weeks | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c \<39 mmol/mol (5.7%) at screening. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With HbA1c < 39 mmol/Mol (5.7%) (for Participants With a Screening HbA1c ≥ 39 mmol/Mol [5.7%]) | At week 52, week 104 | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants with HbA1c ≥ 39 mmol/mol (5.7%) at screening. And, number analyzed = number of participants who contributed to the analysis at that particular timepoint. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Systolic Blood Pressure (SBP) | Week 0, week 104 | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis. | Millimetre of mercury (mmHg) | MEAN |
| SECONDARY | Change in Diastolic Blood Pressure (DBP) | Week 0, week 104 | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis. | mmHg | MEAN |
| SECONDARY | Change in Pulse | Week 0, week 104 | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis. | beats per mintue (bpm) | MEAN |
| SECONDARY | Change in High Sensitivity C-Reactive Protein (hsCRP) - Ratio to Baseline | Week 0, week 104 | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis. | ratio of hsCRP | GEOMETRIC_MEAN |
| SECONDARY | Change in Total Cholesterol - Ratio to Baseline | Week 0, week 104 | FAS included all randomised participants. All participants were analyzed according to the treatment to which they were assigned at randomisation. Here, overall number of participants analyzed = number of participants who contributed to the analysis. | ratio of total cholesterol | GEOMETRIC_MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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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GET https://conductscience.org/api/trials/v1/NCT03574597/outcomes