In a 3-year, randomized, double-blind safety study the incidence of alanine aminotransferase (ALT) elevation ≥3 times the upper limit during treatment with pioglitazone and metformin was comparable to that with glibenclamide and metformin.
In a 3-year randomized double-blind safety study (Spanheimer et al. 2006) the incidence of ALT elevation ≥3 times the upper limit during treatment with pioglitazone and metformin was comparable to that with glibenclamide and metformin.
The Hepatica study is a two-arm, multicenter, randomized, comparative efficacy and safety study.
The Hepatica study is a two-arm, international, multicenter, randomized, comparative efficacy and safety study comparing adjuvant CAPOX vs CAPOX and bevacizumab in patients with resected or resected in combination with ablated colorectal liver metastases.
In one clinical trial, ARC1905 is used for neovascular AMD in combination therapy with either multiple doses or with only one induction dose of intravitreal ranibizumab in a non-randomized, open-label, uncontrolled, safety study (ClinicalTrials.gov Identifier: NCT00709527).
Secondary objectives were to determine the proportion of participants with a 20%, 50%, and 70% improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function subscales at 4, 8, 12, and 24 weeks This was a double-blind, randomized, placebo-controlled, single-dose escalation safety study consisting of 4 dosing cohorts.
A prospective, uncontrolled, non-randomized, dose-escalating, pilot phase 1 safety study in AMD patients with subfoveal CNV has been completed (ClinicalTrials.gov Identifier: NCT00473928).
AleNephro was a randomized, double-blind, active-controlled, parallel-group, multicenter Phase IIb renal function non-inferiority safety study.
Clinical experience with CorCap™ CSD implants in patients with heart failure can be divided into 3 phases: (1) initial safety studies, (2) randomized controlled trials, and (3) limited marketed release.
The gold standard for human safety studies is the randomized clinical trial.
