Isolated Systolic Hypertension in the Elderly and Very Elderly

Isolated Systolic Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751829
• Other study ID #: SE-866/37
• Status: Completed
• Phase: Phase 3
• Start date: July 2003
• Est. completion date: February 2005

Study information

• Verified date: May 2023
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 417
• Est. completion date: February 2005
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Isolated Systolic Hypertension
• Systolic Murmurs

Intervention

Drug:
• olmesartan 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
• nitrendipine + 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean sitting systolic blood pressure as assessed by conventional BP measurements		12 weeks
Secondary	Change in mean sitting systolic blood pressure assessed by conventional BP measurements		After 1, 2, 4, 8, 12, 16, 20, and 24 weeks
Secondary	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