Trial · NCT01079962
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Aortic Pulse Pressure (APP) in Intention to Treat (ITT) Population at Week 12 | Baseline and Week 12 | The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline. |
| Primary | Change From Baseline in Aortic Pulse Pressure (APP) in Per Protocol (PP) Population at Week 12 | Baseline and Week 12 | The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 12 was calculated as APP at Week 12 minus APP at baseline. |
| Secondary | Change From Baseline in Aortic Blood Pressure (BP) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | The change in aortic BP (aortic systolic blood pressure \[SBP\], aortic diastolic blood pressure \[DBP\] and aortic mean blood pressure \[BP\]) at Week 4 and Week 12 was calculated as aortic BP (aortic SBP, aortic DBP and aortic mean BP) at Week 4 and Week 12 minus aortic BP (aortic SBP, aortic DBP and aortic mean BP) at baseline. |
| Secondary | Change From Baseline in Aortic Augmentation Index (AIx) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | Augmentation index is a composite measure of wave reflection and systemic arterial stiffness which was calculated as the difference between the second and first systolic peaks. The change in AIx at Week 4 and Week 12 was calculated as AIx at Week 4 and Week 12 minus AIx at baseline. |
| Secondary | Change From Baseline in Carotid-femoral Pulse Wave Velocity (cfPWV) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | Pulse wave velocity (PWV) is used as a measure of arterial stiffness, which is a measure of the cushioning functioning of major vessels like the aorta. The velocity of the Pulse wave (PW) along an artery is dependent on the stiffness of that artery. The change in cfPWV at Week 4 and Week 12 was calculated as cfPWV at Week 4 and Week 12 minus cfPWV at baseline. |
| Secondary | Change From Baseline in Heart Rate at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | The change in heart rate at Week 4 and Week 12 was calculated as heart rate at Week 4 and Week 12 minus heart rate at baseline. |
| Secondary | Change From Baseline in Aortic Pulse Pressure (APP) at Week 4 | Baseline and Week 4 | The APP was calculated as aortic systolic pressure minus aortic diastolic pressure. The change in APP at Week 4 was calculated as APP at Week 4 minus APP at baseline. |
| Secondary | Change From Baseline in Lipid Levels at Week 12 | Baseline and Week 12 | The lipid levels evaluated were total cholesterol, low density lipoprotein (LDL) cholesterol, and high density lipoprotein (HDL) cholesterol blood concentrations. The change in lipid levels at Week 12 was calculated as lipid levels at Week 12 minus lipid levels at baseline. |
| Secondary | Change From Baseline in Blood Glucose Levels at Week 12 | Baseline and Week 12 | The change in blood glucose level at Week 12 was calculated as blood glucose level at Week 12 minus blood glucose level at baseline. |
| Secondary | Change From Baseline in Brachial Blood Pressure (BP) at Week 4 and Week 12 | Baseline, Week 4 and Week 12 | The change in brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 was calculated as brachial BP (brachial SBP, brachial DBP and brachial mean BP) at Week 4 and Week 12 minus brachial BP (brachial SBP, brachial DBP and brachial mean BP) at baseline. |
| Secondary | Number of Participants With Adverse Events (AEs) | Baseline up to Week 14 (follow-up visit) | An adverse event (AE) was defined as any untoward medical occurrence in the form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. |
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.
For software
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