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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
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Birmingham, Alabama, United States
Mobile, Alabama, United States
Muscle Shoals, Alabama, United States
Searcy, Arkansas, United States
Carmichael, California, United States
Spring Valley, California, United States
Coral Gables, Florida, United States
Deerfield Beach, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Start Date
December 1, 2006
Primary Completion Date
October 1, 2007
Completion Date
October 1, 2007
Last Updated
October 2, 2018
278
ACTUAL participants
olmesartan medoxomil + hydrochlorothiazide, if necessary
DRUG
Placebo
DRUG
Lead Sponsor
Daiichi Sankyo
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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