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

Daiichi Sankyo144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Essential Hypertension

Interventions

olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessaryDRUG

olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks

Eligibility

Sex: ALLMin age: 30 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg 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

Time frame: 4 - 9 wks of olmesartan monotherapy

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)

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

Time frame: 4 to 9 weeks on combination therapy

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)

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.

Time frame: 4 to 9 weeks

Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)

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.

Time frame: 4 - 9 weeks

Data from ClinicalTrials.gov

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