PASSReviewer 1· 85% conf
The study design includes randomization, blinding, a power analysis, inclusion/exclusion criteria, and missing-data handling, though the randomization method and blinding stages are not fully detailed.
Evidence
direct quote[Methods, Trial Design]
“Randomization was stratified by baseline hypertension status (uncontrolled hypertension, resistant hypertension) and baseline seated-SBP (<145, ≥145 mmHg).”direct quote[Methods, Statistical Analyses]
“It was estimated that 720 participants would need to be randomized to achieve 98% power to detect a mean (standard deviation [SD]) difference of 6 (15) mmHg for change from baseline in seated-SBP at week 12 in favor of baxdrostat versus placebo using a two-sample t-test with a two-sided significance level of 0.025.”direct quote[Methods, Statistical Analyses]
“Missing data at week 12 following treatment discontinuation were imputed using a multiple imputation retrieved dropout method and missing data at week 12 following initiation of rescue medication were imputed using a multiple imputation washout method.”PASSReviewer 2· 100% conf
The study design is rigorous with adequate randomization, blinding, power analysis, inclusion/exclusion criteria, and handling of missing data.
Evidence
direct quote[Methods, Trial Design, Population, and Procedures, paragraph 3]
“Participants were randomly assigned 1:1:1 to receive baxdrostat 1 mg, baxdrostat 2 mg, or placebo once daily. Randomization was stratified by baseline hypertension status (uncontrolled hypertension, resistant hypertension) and baseline seated-SBP (<145, ≥145 mmHg).”direct quote[Methods, Statistical Analyses, paragraph 2]
“It was estimated that 720 participants would need to be randomized to achieve 98% power to detect a mean (standard deviation [SD]) difference of 6 (15) mmHg for change from baseline in seated-SBP at week 12 in favor of baxdrostat versus placebo using a two-sample t-test with a two-sided significance level of 0.025.”paraphrase[Methods, Statistical Analyses, paragraph 2 and Table 2 footnote]
“Missing data at week 12 were imputed using multiple imputation retrieved dropout method for treatment discontinuation and washout method for rescue medication initiation.”PASSReviewer 3· 95% conf
The study design is rigorous with adequate blinding, power analysis, inclusion criteria, and missing data handling, but the randomization method is not explicitly described.
Evidence
direct quote[Methods, paragraph 3]
“Participants were randomly assigned 1:1:1 to receive baxdrostat 1 mg, baxdrostat 2 mg, or placebo once daily. Randomization was stratified by baseline hypertension status (uncontrolled hypertension, resistant hypertension) and baseline seated-SBP (<145, ≥145 mmHg).”direct quote[Methods, paragraph 1]
“BaxHTN is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial”direct quote[Statistical Analyses, paragraph 2]
“It was estimated that 720 participants would need to be randomized to achieve 98% power to detect a mean (standard deviation [SD]) difference of 6 (15) mmHg for change from baseline in seated-SBP at week 12 in favor of baxdrostat versus placebo using a two-sample t-test with a two-sided significance level of 0.025.”