Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

NCT00751751 | Completed Phase 3

• 1 other identifier: SE-866/36
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (2)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary

2

ACTIVE COMPARATOR

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.

Drug: losartan + hydrochlorothiazide, if necessary

Interventions

olmesartan medoxomil + hydrochlorothiazide, if necessary DRUG

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

1

losartan + hydrochlorothiazide, if necessary DRUG

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.

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP \>=150 mm HG

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company: lead

Study Sites (1)

Unknown Facility

Darmstadt, Germany

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Olmesartan Medoxomil; Hydrochlorothiazide; Losartan

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Peter U Witte, MD, Ph.D.

  IMFORM GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: June 1, 2003
• Primary Completion: April 1, 2005
• Study Completion: June 1, 2005
• Last Updated: September 12, 2008

Record last verified: 2008-09

Locations

DE (1)