Study of Co-administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

December 20, 2018 updated by: Daiichi Sankyo, Inc.

A Randomized, Double-blind, Placebo-controlled Factorial Study Evaluating the Efficacy and Safety of Co-administration of Olmesartan Medoxomil Plus Amlodipine Compared to Monotherapy in Patients With Mild to Severe Hypertension

This study assesses the efficacy and safety of co-administration of olmesartan medoxomil plus amlodipine in mild to severe hypertensive patients older than 18 years of age

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

1900

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

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Huntsville, Alabama, United States
      • Mobile, Alabama, United States
      • Muscle Shoals, Alabama, United States
      • Tuscumbia, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Beverly Hills, California, United States
      • Buena Park, California, United States
      • Cypress, California, United States
      • Encino, California, United States
      • Fountain Valley, California, United States
      • La Jolla, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Los Gatos, California, United States
      • Pico Rivera, California, United States
      • Rancho Mirage, California, United States
      • Roseville, California, United States
      • Sacramento, California, United States
      • San Francisco, California, United States
      • Santa Ana, California, United States
      • Spring Valley, California, United States
      • Temecula, California, United States
      • Tustin, California, United States
      • Walnut Creek, California, United States
    • Colorado
      • Golden, Colorado, United States
    • Connecticut
      • Bristol, Connecticut, United States
      • Stratford, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Clearwater, Florida, United States
      • Coral Gables, Florida, United States
      • Daytona Beach, Florida, United States
      • DeLand, Florida, United States
      • Fort Lauderdale, Florida, United States
      • Hialeah, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Kissimmee, Florida, United States
      • Merritt Island, Florida, United States
      • Miami, Florida, United States
      • New Port Richey, Florida, United States
      • Ocala, Florida, United States
      • Orlando, Florida, United States
      • Palm Harbor, Florida, United States
      • Pembroke Pines, Florida, United States
      • Pinellas Park, Florida, United States
      • Sarasota, Florida, United States
      • Sebastian, Florida, United States
      • Stuart, Florida, United States
      • Tamarac, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
      • Blairsville, Georgia, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
      • Indianapolis, Indiana, United States
    • Kansas
      • Arkansas City, Kansas, United States
      • Shawnee Mission, Kansas, United States
    • Kentucky
      • Erlanger, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Maine
      • Auburn, Maine, United States
    • Maryland
      • Oxon Hill, Maryland, United States
    • Michigan
      • Benzonia, Michigan, United States
      • Cadillac, Michigan, United States
      • Livonia, Michigan, United States
      • Troy, Michigan, United States
    • Minnesota
      • Brooklyn Center, Minnesota, United States
    • Mississippi
      • Olive Branch, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Montana
      • Butte, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Henderson, Nevada, United States
    • New Jersey
      • Berlin, New Jersey, United States
      • Elizabeth, New Jersey, United States
      • Hackensack, New Jersey, United States
      • South Bound Brook, New Jersey, United States
      • Turnersville, New Jersey, United States
    • New York
      • East Syracuse, New York, United States
      • Manlius, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Kinston, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Statesville, North Carolina, United States
      • Wilmington, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
      • Lyndhurst, Ohio, United States
      • Marion, Ohio, United States
      • Mogadore, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Beaver, Pennsylvania, United States
      • Bensalem, Pennsylvania, United States
      • Downingtown, Pennsylvania, United States
      • Feasterville, Pennsylvania, United States
      • Fleetwood, Pennsylvania, United States
      • Lansdale, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Uniontown, Pennsylvania, United States
    • Rhode Island
      • Cranston, Rhode Island, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Charleston, South Carolina, United States
      • Greer, South Carolina, United States
      • Mount Pleasant, South Carolina, United States
      • Simpsonville, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Nashville, Tennessee, United States
      • New Tazewell, Tennessee, United States
    • Texas
      • Arlington, Texas, United States
      • Austin, Texas, United States
      • Carrollton, Texas, United States
      • Corpus Christi, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Lake Jackson, Texas, United States
      • Midland, Texas, United States
      • New Braunfels, Texas, United States
      • San Angelo, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Burke, Virginia, United States
      • Norfolk, Virginia, United States
      • Richmond, Virginia, United States
      • Suffolk, Virginia, United States
    • Washington
      • Lakewood, Washington, United States
      • Olympia, Washington, United States
    • West Virginia
      • Charleston, West Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, 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:

  • Male or female patients
  • 18 years of age or older (20% equal to or older than 65 years)
  • With mild to severe hypertension defined as seated diastolic blood pressure of 95-120 mmHg while off any hypertensive medication

Exclusion Criteria:

  • Patients should not have serious concomitant conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patients

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

Secondary Outcome Measures

Outcome Measure
To evaluate the number (%) of patients achieving BP goal.
To characterize the pharmacokinetic interactions and the corresponding pharmacodynamic (BP) correlation

Collaborators and Investigators

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

Sponsor

Daiichi Sankyo, Inc.

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

May 1, 2005

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Actual)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS8663-A-U301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

IPD Sharing Time Frame

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

IPD Sharing Access Criteria

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

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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