NCT00430638

A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Detailed description

This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows: * First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo * Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo * Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo * Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo * Subjects with a mean BP of \<120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication. * Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above. * Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	olmesartan medoxomil + hydrochlorothiazide, if necessary	olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
DRUG	Placebo	Oral tablets administered for once daily for 12 weeks

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-02-02
• Last updated: 2018-10-02
• Results posted: 2010-01-22

Locations

29 sites across 1 country: United States