Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751751

Enrollment

441

Registered

2008-09-12

Start date

2003-06-30

Completion date

2005-06-30

Last updated

2008-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Brief summary

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.

Interventions

DRUGolmesartan medoxomil + hydrochlorothiazide, if necessary

oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP

DRUGlosartan + hydrochlorothiazide, if necessary

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements	12 weeks

Secondary

Measure	Time frame
Change in mean sitting diastolic BP assessed by conventional BP measurements	after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP	after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026