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A comparison of the change in BP from baseline to the end of phase 3 between the initial monotherapy and combination therapy limbs.
A comparison of the change in left ventricular mass (cardiac hypertrophy) and aortic pulse wave velocity (arterial stiffness) from baseline to the end of phase 3 between the initial monotherapy and combination therapy groups.
An analysis of how the baseline covariates of age, gender, renin mass, weight, height, thoracic bioimpedance and arterial stiffness prior treatment of BP etc. predict the differences in Δsystolic BP between the initial monotherapy and combination therapy limbs.
Box 2 Secondary end points A comparison of the proportion of patients who drop out of the trial at any stage after randomisation or who require additional antihypertensive drug therapy in phase 3 of the trial between the initial monotherapy and combination therapy limbs.
A comparison of the change in thoracic bioimpedance and arterial stiffness from baseline to the end of phase 1 and then separately to the end of phase 2 between the initial monotherapy and combination therapy limbs and how this predicts the primary end point.
Similar(55)
45 As beta cell function declines, intensified treatment beyond the initial monotherapy regimen is required.
The relapse rate was higher for ACTH as compared to Vigabatrin (55.5% against 33.3%) when considering the initial monotherapy.
In the case of metformin failure, the only clinical trial meeting the inclusion criteria included 103 patients in whom glibenclamide was added to the initial monotherapy (metformin + glibenclamide) and 104 patients who continued metformin monotherapy (control group).
32 The 2 clinical trials selected for glibenclamide failure included 350 patients in whom metformin was added to the initial monotherapy (glibenclamide + metformin) and 341 patients who continued glibenclamide monotherapy (control group).
If combination is superior in this analysis, then the averaged mean HSBP between initial monotherapy and initial combination therapy at the end of phase 2 will be compared.
Secondary end points are detailed in box 2. In addition there will be a substudy in three sites using cardiac MRI to compare the change in left ventricular mass and aortic pulse wave velocity (arterial stiffness) between initial combination and initial monotherapy groups for which consent is sought separately.
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