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Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
olmesartan medoxomil + hydrochlorothiazide, if necessary
losartan + hydrochlorothiazide, if necessary
Sponsored by
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm 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

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.

Outcomes

Primary Outcome Measures

Change in mean sitting diastolic blood pressure assessed by conventional BP measurements

Secondary Outcome Measures

Change in mean sitting diastolic BP assessed by conventional BP measurements
Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP

Full Information

First Posted
September 11, 2008
Last Updated
September 11, 2008
Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
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1. Study Identification

Unique Protocol Identification Number
NCT00751751
Brief Title
Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly
Official Title
Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
441 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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
Arm Title
2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
olmesartan medoxomil + hydrochlorothiazide, if necessary
Intervention Description
oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP
Intervention Type
Drug
Intervention Name(s)
losartan + hydrochlorothiazide, if necessary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in mean sitting diastolic BP assessed by conventional BP measurements
Time Frame
after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
Title
Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP
Time Frame
after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter U Witte, MD, Ph.D.
Organizational Affiliation
IMFORM GmbH
Official's Role
Principal Investigator
Facility Information:
City
Darmstadt
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

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