Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Essential Hypertension

Treatments: Drug: losartan + hydrochlorothiazide, if necessary; Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary

Study type: Interventional

Funder types: Industry

Identifiers

NCT00751751

SE-866/36

Details and patient eligibility

About

To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.

Enrollment: 441 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 65 years or older
• Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG

Exclusion criteria

• Secondary hypertension
• Malignant hypertension
• Severe heart failure (NYHA III-IV)
• History or evidence of renal disease
• Recent history of myocardial infarction
• Hypersensitivity to study drugs
• History of drug or alcohol abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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441 participants in 2 patient groups

1

Experimental group

Description:

oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks

Treatment:

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary

2

Active Comparator group

Description:

oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP.

Treatment:

Drug: losartan + hydrochlorothiazide, if necessary