NCT00751829

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

September 11, 2008

Last Update Submit

May 31, 2023

Conditions

Isolated Systolic Hypertension

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (2)

  • 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

Study Arms (2)

1

EXPERIMENTAL

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 controll BP

Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary

2

ACTIVE COMPARATOR

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

Drug: nitrendipine + hydrochlorothiazide, if necessary

Interventions

olmesartan medoxomil + hydrochlorothiazide, if necessaryDRUG

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

1
nitrendipine + hydrochlorothiazide, if necessaryDRUG

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

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 or older
  • Mean sitting BP \>160 mmHg and mean sitting dBP\<90 mmHg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Munich, Germany

Location

MeSH Terms

Conditions

Isolated Systolic Hypertension

Interventions

Olmesartan MedoxomilHydrochlorothiazideNitrendipine

Condition Hierarchy (Ancestors)

Essential HypertensionHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDihydropyridinesPyridines

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

July 1, 2003

Primary Completion

October 1, 2004

Study Completion

February 1, 2005

Last Updated

June 1, 2023

Record last verified: 2023-05

Locations

DE(1)