Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

Phase 4

Completed

• Conditions: Essential Hypertension
• Interventions: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

• Registration Number: NCT00890591
• Lead Sponsor: Daiichi Sankyo

Brief Summary

In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2007-06
• Study Completion: 2007-08
• Study First Submitted: 2009-02-11
• Results First Submitted: 2009-02-11
• Study First Submitted QC: 2009-03-20
• Results First Submitted QC: 2009-03-20
• Study First Posted: 2009-04-30
• Results First Posted: 2009-04-30
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Stage 1 and 2 hypertension without treatment for at least 2 weeks
• Women with no risk of becoming pregnant

Exclusion Criteria

• Study participation could result in risk to health of subject
• Cardiovascular disease
• Secondary hypertension or stage 3 hypertension
• Myocardial infarction within the last 6 months
• Congestive heart failure
• Pulmonary edema
• Valvular alterations or rheumatic cardiopathy
• Clinically relevant conduction disorders significant arrhythmias
• Alcohol or illicit drug use
• Medication abuse
• Pregnant or nursing women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary	-

Primary Outcome Measures

Name	Time	Method
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)	4 - 9 wks of olmesartan monotherapy	Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)	4 to 9 weeks on combination therapy	Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)	4 to 9 weeks	Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.
Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)	4 - 9 weeks	Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.