Study of co-Administration of Olmesartan Medoxomil Plus Amlodipine in Patients With Mild to Severe Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00185133
First received: September 9, 2005
Last updated: December 12, 2007
Last verified: December 2007
  Purpose

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


Condition Intervention Phase
Hypertension
Drug: Olmesartan medoxomil
Drug: Amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change from baseline in trough seated systolic blood pressure and seated diastolic blood pressure for each treatment arm

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

Estimated Enrollment: 1900
Study Start Date: May 2005
Estimated Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185133

  Hide Study Locations
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
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
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
United States, Colorado
Golden, Colorado, United States
United States, Connecticut
Bristol, Connecticut, United States
Stratford, Connecticut, United States
United States, Delaware
Newark, Delaware, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Clearwater, Florida, United States
Coral Gables, Florida, United States
Daytona Beach, Florida, United States
Deland, Florida, United States
Ft. 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
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Atlanta, Georgia, United States
Blairsville, Georgia, United States
United States, Idaho
Boise, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Evansville, Indiana, United States
Indianapolis, Indiana, United States
United States, Kansas
Arkansas City, Kansas, United States
Shawnee, Kansas, United States
United States, Kentucky
Erlanger, Kentucky, United States
United States, Louisiana
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
United States, Maine
Auburn, Maine, United States
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Oxon Hill, Maryland, United States
United States, Michigan
Benzonia, Michigan, United States
Cadillac, Michigan, United States
Livonia, Michigan, United States
Troy, Michigan, United States
United States, Minnesota
Brooklyn Center, Minnesota, United States
United States, Mississippi
Olive Branch, Mississippi, United States
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Kansas City, Missouri, United States
United States, Montana
Butte, Montana, United States
United States, Nebraska
Omaha, Nebraska, United States
United States, Nevada
Henderson, Nevada, United States
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
United States, New York
East Syracuse, New York, United States
Manlius, New York, United States
Rochester, New York, United States
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
United States, Ohio
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Mogadore, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
United States, Oregon
Eugene, Oregon, United States
Portland, Oregon, United States
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
United States, Rhode Island
Cranston, Rhode Island, United States
United States, South Carolina
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Simpsonville, South Carolina, United States
United States, Tennessee
Bristol, Tennessee, United States
Nashville, Tennessee, United States
New Tazewell, Tennessee, United States
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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
United States, Utah
Salt Lake City, Utah, United States
United States, Virginia
Burke, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Suffolk, Virginia, United States
United States, Washington
Lakewood, Washington, United States
Olympia, Washington, United States
United States, West Virginia
Charleston, West Virginia, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Reinilde Heyrman, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00185133     History of Changes
Other Study ID Numbers: CS8663-A-U301
Study First Received: September 9, 2005
Last Updated: December 12, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Treatment of high blood pressure in mild to severe hypertensive patients

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Olmesartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on August 25, 2014