An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes

September 28, 2016 updated by: Daiichi Sankyo, Inc.

A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Type II Diabetic Patients With Hypertension

This study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with Type II diabetes and high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 4

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Mesa, Arizona, United States
    • Arkansas
      • Searcy, Arkansas, United States
    • California
      • Los Angeles, California, United States
      • Roseville, California, United States
      • Tustin, California, United States
    • Florida
      • Deland, Florida, United States
      • Pembroke Pines, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Kansas
      • Wichita, Kansas, United States
    • Kentucky
      • Madisonville, Kentucky, United States
    • Maine
      • Auburn, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Oxon Hill, Maryland, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Missouri
      • Florissant, Missouri, United States
    • New York
      • Williamsville, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
    • Tennessee
      • New Talenwell, Tennessee, United States
      • New Tazewell, Tennessee, United States
    • Texas
      • Colleyville, Texas, United States
      • Corpus Christi, Texas, United States
      • Richardson, Texas, United States
    • Utah
      • Murray, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with Type II diabetes that are on stable treatment with hypoglycemic agents
  • Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but <200 mmHg and a MSDBP less than or equal to 114 mmHg following a 3 to 4-week single-blind placebo run-in period
  • The difference in MSSBP between Visits 3 and 4 or between Visits 4 and 4X must be less than or equal to 10 mmHg
  • Patients with a mean daytime (8AM - 4PM) SBP > 130 mmHg and less than or equal to 199 mmHg and a mean daytime DBP less than or equal to 114 as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period
  • If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study

Exclusion Criteria:

  • History of stroke or transient ischemic attack (TIA) within the last one year
  • History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
  • Presence of overt proteinuria at screening
  • Severe hypertension (DBP greater than or equal to 115 mmHg or SBP greater than or equal to 200 mmHg)
  • Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
  • Type I or Type II diabetes requiring insulin
  • Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease
  • Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial fibrillation, or Atrial Flutter

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active treatment
Blood pressure (BP) measurements were taken every three weeks for 12 weeks. In accordance with their BP results, participants either stayed on their current medication or were started on the next higher regimen at the 3, 6, or 9 week visits. All participants began at 20 mg olmesartan, once daily for 3 weeks. The next higher regimen was olmesartan 40 mg, followed by olmesartan 40 mg + 12.5 mg hydrochlorothiazide, followed by olmesartan 40 mg + 25 mg of hydrochlorothiazide.
Drug: olmesartan medoxomil
Olmesartan medoxomil tablets, once daily
Drug: Olmesartan medoxomil plus Hydrochlorothiazide
Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM.
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic).
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period.
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic)
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks
Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period.
Time Frame: baseline and 12 Weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 Weeks
Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period.
Time Frame: baseline and 12 weeks
Participants had a 24-hour ambulatory blood pressure session at baseline and after 12 weeks of treatment. This outcome measure pooled all participants regardless of their titration history during the study.
baseline and 12 weeks

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 22, 2006

First Submitted That Met QC Criteria

November 22, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

November 3, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 866-449

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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