NCT00185172

Brief Summary

To test the efficacy and safety of olmesartan in patients with essential hypertension.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
2,333

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2002

Typical duration for phase_3

Geographic Reach
8 countries

8 active sites

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

January 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

April 29, 2008

Status Verified

April 1, 2008

Enrollment Period

3.4 years

First QC Date

September 12, 2005

Last Update Submit

April 28, 2008

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan.

    From week 8 to week 12

Secondary Outcomes (2)

  • To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12.

    12 weeks

  • To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.

    12 weeks

Study Arms (3)

1

PLACEBO COMPARATOR

2 week placebo run-in

Other: placebo

2

EXPERIMENTAL

Olmesartan medoxomil tablets for 8 weeks

Drug: olmesartan medoxomil

3

EXPERIMENTAL

Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks

Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets

Interventions

placeboOTHER

Placebo oral tablets for 2 weeks

1
olmesartan medoxomilDRUG

olmesartan medoxomil oral tablets for 8 weeks

2
olmesartan medoxomil oral tablets, hydrochlorothiazide oral tabletsDRUG

olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets

3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 (19 if required by local authorities) to 75 years
  • Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized
  • Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg
  • Written Informed Consent
  • Mentally competent
  • Negative pregnancy test in women at a childbearing age at the beginning of the study

You may not qualify if:

  • Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension
  • Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months
  • Patients with a history or current evidence of congestive heart failure
  • Bilateral renal artery stenosis
  • Severe renal insufficiency (serum creatinine greater than 200 micro mol/l)
  • Severe hepatic impairment or biliary obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Result Cro

Vienna, 1130, Austria

Location

INPUT GmbG

Aachen, 52074, Germany

Location

Biokos Farma s.r.l.

Bologna, 40122, Italy

Location

IMRO TRAMARKO International bv

Berghem, 5352, Netherlands

Location

EUROTRIALS Lda

Lisbon, 1070-274, Portugal

Location

Phidea S.L.

Madrid, 28002, Spain

Location

PFC Pharma Focus Consultants AG

Zurich, Volketswil, 8604, Switzerland

Location

Inveresk Ltd.

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Olmesartan MedoxomilHydrochlorothiazide

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Prof. Michael Bohm, MD

    Universitatskliniken des Saarlandes, Homburg, Germany

    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 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2002

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 29, 2008

Record last verified: 2008-04

Locations

ES(1)PT(1)GB(1)NL(1)AU(1)CH(1)DE(1)IT(1)