Isolated Systolic Hypertension in the Elderly and Very Elderly

Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751829

Enrollment

417

Registered

2008-09-12

Start date

2003-07-31

Completion date

2005-02-28

Last updated

2023-06-01

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

Conditions

Isolated Systolic Hypertension

Brief summary

To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.

Interventions

DRUGolmesartan medoxomil + hydrochlorothiazide, if necessary

oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP

DRUGnitrendipine + hydrochlorothiazide, if necessary

oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily 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 or older * Mean sitting BP \>160 mmHg and mean sitting dBP\<90 mmHg

Exclusion criteria

* Secondary hypertension * Malignant hypertension * Severe Heart Failure (NYHA III-IV) * Recent history of myocardial infarction * Hypersensitivity to study medications * History of drug or alcohol abuse * History or evidence of renal disease

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change in mean sitting systolic blood pressure assessed by conventional BP measurements	After 1, 2, 4, 8, 12, 16, 20, and 24 weeks
Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP	after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment

Countries

Germany

Outcome results

None listed

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