NCT00856271

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_3

Geographic Reach
1 country

5 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

August 1, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
Last Updated

September 29, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

March 3, 2009

Last Update Submit

September 28, 2010

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change of trough seated diastolic blood pressure from baseline to 8 weeks

    Baseline to 8 weeks

Study Arms (2)

1

EXPERIMENTAL

olmesartan medoxomil

Drug: olmesartan medoxomil

2

ACTIVE COMPARATOR

losartan potassium

Drug: losartan potassium

Interventions

olmesartan medoxomilDRUG

oral tablets, once daily for 8 weeks

1
losartan potassiumDRUG

capsules, once daily for 8 weeks

2

Eligibility Criteria

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

You may qualify if:

  • mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and \<110 mmHg, mean seated systolic blood pressure \< 180 mmHg)
  • able to give written informed consent

You may not qualify if:

  • known or suspected secondary hypertension
  • history of chronic hepatic diseases
  • obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
  • cardiac arrhythmia
  • unstable angina pectoris
  • congestive heart insufficiency (New York Heart Association classification III-IV)
  • bilateral renal artery stenosis
  • isolated renal artery stenosis
  • post renal transplantation
  • history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
  • retina bleeding/effusion
  • insulin dependent diabetes mellitus
  • uncontrolled non-insulin dependent diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Beijing, China

Location

Unknown Facility

Chongqing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shanghai, China

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

Olmesartan MedoxomilLosartan

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesBiphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Vice President

    Sankyo Shanghai Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 5, 2009

Study Start

August 1, 2004

Primary Completion

February 1, 2005

Study Completion

April 1, 2005

Last Updated

September 29, 2010

Record last verified: 2010-09

Locations

CN(5)