Olmesartan in Essential Hypertension

April 28, 2008 updated by: Sankyo Pharma Gmbh

Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2333

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1130
        • Result Cro
  • Germany
      • Aachen, Germany, 52074
        • INPUT GmbG
  • Italy
      • Bologna, Italy, 40122
        • Biokos Farma s.r.l.
  • Netherlands
      • Berghem, Netherlands, 5352
        • IMRO TRAMARKO International bv
  • Portugal
      • Lisboa, Portugal, 1070-274
        • EUROTRIALS Lda
  • Spain
      • Madrid, Spain, 28002
        • Phidea S.L.
  • Switzerland
    • Volketswil
      • Zurich, Volketswil, Switzerland, 8604
        • PFC Pharma Focus Consultants AG
  • United Kingdom
      • Edinburgh, United Kingdom
        • Inveresk Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
2 week placebo run-in
Other: placebo
Placebo oral tablets for 2 weeks
Experimental: 2
Olmesartan medoxomil tablets for 8 weeks
Drug: olmesartan medoxomil
olmesartan medoxomil oral tablets for 8 weeks
Experimental: 3
Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks
Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets
olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: From week 8 to week 12
From week 8 to week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 12 weeks
12 weeks
To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sankyo Pharma Gmbh

Investigators

  • Principal Investigator: Prof. Michael Bohm, MD, Universitatskliniken des Saarlandes, Homburg, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

April 29, 2008

Last Update Submitted That Met QC Criteria

April 28, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP-OLM-01-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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