NCT00890591

Brief Summary

In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_4

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

April 30, 2009

Completed
Last Updated

June 3, 2009

Status Verified

May 1, 2009

Enrollment Period

10 months

First QC Date

February 11, 2009

Results QC Date

February 11, 2009

Last Update Submit

May 27, 2009

Conditions

Essential Hypertension

Keywords

hypertensionangiotensin II type 1 receptor blockerolmesartan

Outcome Measures

Primary Outcomes (4)

  • Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy)

    Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level

    4 - 9 wks of olmesartan monotherapy

  • Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide)

    Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks

    4 to 9 weeks on combination therapy

  • Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide)

    Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was \> or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks.

    4 to 9 weeks

  • Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine)

    Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy.

    4 - 9 weeks

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary

Interventions

olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessaryDRUG

olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks

Treatment

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage 1 and 2 hypertension without treatment for at least 2 weeks
  • Women with no risk of becoming pregnant

You may not qualify if:

  • Study participation could result in risk to health of subject
  • Cardiovascular disease
  • Secondary hypertension or stage 3 hypertension
  • Myocardial infarction within the last 6 months
  • Congestive heart failure
  • Pulmonary edema
  • Valvular alterations or rheumatic cardiopathy
  • Clinically relevant conduction disorders significant arrhythmias
  • Alcohol or illicit drug use
  • Medication abuse
  • Pregnant or nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Essential HypertensionHypertension

Interventions

Olmesartan MedoxomilHydrochlorothiazideAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Howard Kessler
Organization
Daiichi Sankyo Pharma Development
hmkessler@dsus.com
732-590-5032

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 11, 2009

First Posted

April 30, 2009

Study Start

August 1, 2006

Primary Completion

June 1, 2007

Study Completion

August 1, 2007

Last Updated

June 3, 2009

Results First Posted

April 30, 2009

Record last verified: 2009-05