Olmesartan/HCTZ 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Essential Hypertension
Status:
Completed
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to assess the anti-hypertensive effect of OM/HCTZ
40/12.5 mg combination therapy compared to OM 40 mg monotherapy in lowering sitting diastolic
BP in hypertensive patients after 8 weeks of double-blind treatment.
The study consisted of two sequential phases of 8 weeks duration each:
During the first phase, OM 40 mg monotherapy was compared with OM/HCTZ 40/12.5 mg in order to
evaluate the additional benefit of OM/HCTZ 40/12.5 mg in the treatment of essential moderate
to severe hypertension.
During the second phase, patients whose BP proved to be insufficiently controlled by the OM
40 mg monotherapy were to start OM/HCTZ 40/12.5 mg combination therapy while patients whose
BP proved to be insufficiently controlled by the OM/HCTZ 40/12.5 mg combination were to be
up-titrated to the OM/HCTZ 40/25 mg combination to evaluate the additional benefit of the
up-titrated combination.
The study was be conducted by qualified and experienced personnel with adherence to GCP,
current guidelines on the design of studies in hypertension, the applicable regulatory
requirements and the ethical principles based on the Declaration of Helsinki.
Phase:
Phase 3
Details
Lead Sponsor:
Menarini Group
Collaborators:
Daiichi Sankyo Europe, GmbH Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company