EMA: Scientific guideline: Guideline on clinical investigation of medicinal products in the treatment of hypertension
Guidance is provided on the design of clinical studies considered to be of relevance for the evaluation of antihypertensive drugs. The current revision concerns fixed combinations in therapeutic doses for first line therapy. The guideline revision acknowledges the increasing use of fixed drug combinations in the treatment of hypertension. Recent treatment guidelines, issued by scientific societies, address the fact that certain, more severely ill hypertensive patients, could be treated with more than one drug from the start of therapy.