Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Essential Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751751
• Other study ID #: SE-866/36
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: September 11, 2008
• Start date: June 2003
• Est. completion date: June 2005

Study information

• Verified date: September 2008
• Source: Daiichi Sankyo Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 441
• Est. completion date: June 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• olmesartan 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
• losartan + 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Europe, GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean sitting diastolic blood pressure assessed by conventional BP measurements		12 weeks	No
Secondary	Change in mean sitting diastolic BP assessed by conventional BP measurements		after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks	No
Secondary	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	No