Because the study was an explanatory trial, it was determined a priori to exclude from the main analysis patients with compliance less than 90% of prescribed medication (questioning, counting of tablets), patients with clinical or laboratory adverse effects requiring discontinuation of treatment, patients lost to follow-up before the end of the study, patients who developed a severe disease requiring the prescription of treatment(s) incompatible with the protocol and patients who did not have satisfactory blood pressure modification defined by a sitting diastolic blood pressure higher than or equal to 115 mmHg (or lower at the discretion of the investigator).
After screening and obtaining informed consent, a physical examination, electrocardiogram and screening blood tests were performed. Patients qualifying were then given a one-month supply of placebo tablets (one pink and one white, identical to the study indapamide and HCTZ tablets) and were asked to continue on their usual diet. buy ampicillin
Patients with qualifying pressures and compliance after one month of placebo run-in were then randomly assigned to indapamide or HCTZ, and given a four-week supply of pink and white tablets.
Random assignment to treatment group and provision of study medication were carried out in the hospital pharmacy.