Methods |
Single‐blind placebo run‐in period of 2‐4 weeks followed by randomization into double‐blind treatment period of 8 weeks. ABPM was performed at randomization and at the end of the treatment period |
Participants |
Participants with uncomplicated primary hypertension, with a mean sitting DBP ≥ 100 mmHg and ≤ 120 mmHg, and mean sitting SBP that did not differ by more than 10 mmHg at screening and randomization visit, were randomized (308 participants) and evaluated for tolerability and safety. 307 participants were included in the intention‐to‐treat analysis of efficacy (1 participant discontinued before any post‐randomization efficacy data gathered). Trial completed by 285 participants |
Interventions |
Amlodipine 5 mg/benazepril 20 mg (administered as separate components), amlodipine 5 mg, benazepril 20 mg, or placebo once daily around 8 a.m. (77 participants per group at randomization) |
Outcomes |
Efficacy, tolerability, and safety of dual therapy with a calcium antagonist and angiotensin‐converting enzyme inhibitor |
Notes |
Only DBP provided. Contact information for first author could not be found |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
No description of the process of randomization |
Allocation concealment (selection bias) |
Unclear risk |
No description of the process |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
No description of the process |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No description of the process |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing participants relatively balanced across groups |
Selective reporting (reporting bias) |
Low risk |
All outcomes in methods were reported |
Other bias |
High risk |
Funded by Ciba‐Geigy Corporation |