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Blood Pressure Lowering Ability and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Patients With Stage I and Stage II Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00527514
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : September 23, 2009
Last Update Posted : November 11, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Amlodipine Drug: Olmesartan medoxomil plus amlodipine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects With Stage 1 and Stage 2 Hypertension
Study Start Date : September 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Amlodipine
Tablets
Drug: Olmesartan medoxomil plus amlodipine
Tablets


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring [ Time Frame: Baseline to 12 Weeks ]

Secondary Outcome Measures :
  1. Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure [ Time Frame: Baseline to 12 weeks ]
  2. Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group. [ Time Frame: Baseline to end of week 3 ]
  3. Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group. [ Time Frame: Baseline to end of week 6 ]
  4. Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group [ Time Frame: Baseline to end of week 9 ]
  5. Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group [ Time Frame: Baseline to end end of week 12 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females greater than or equal to 18 years of age
  • Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mm Hg but less than or equal to 199 mm Hg or a mean seated diastolic blood pressure (MSDBP) greater than or equal to 90 mm Hg and less than or equal to 109 mm Hg, following a period of taking only placebo
  • Patients with a mean daytime (8AM-4PM) systolic blood pressure greater than or equal to 135 mm Hg and less than or equal to 199 mm Hg and a mean daytime diastolic blood pressure less than or equal to 109 mm Hg as measured by an ambulatory blood pressure monitoring device (ABPM), after a period of taking only placebo
  • If female, must have negative serum pregnancy test at screening and be either post-menopausal (greater than or equal to 1 year), 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, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months
  • Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma, or Cushing's syndrome
  • Type I diabetes. Patients with Type II diabetes on stable treatment, with fasting glucose <160 mg/dl may enroll
  • Patients with hemodynamically significant cardiac valvular disease
  • Patients with clinically significant cardiac conduction defects, including second or third degree AV block, left bundle branch block, sick sinus syndrome, atrial fibrillation, atrial flutter, an accessory bypass tract, or any arrhythmia requiring medication
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00527514


Locations
United States, California
Buena Park, California, United States
Long Beach, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Tustin, California, United States
Westlake Village, California, United States
United States, Colorado
Castle Rock, Colorado, United States
United States, Florida
Pembroke Pines, Florida, United States
United States, Illinois
Orland Park, Illinois, United States
United States, Massachusetts
Natick, Massachusetts, United States
United States, New York
New York, New York, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cincinnati, Ohio, United States
United States, Pennsylvania
Beaver, Pennsylvania, United States
United States, South Carolina
Greer, South Carolina, United States
United States, Texas
Carrolton, Texas, United States
Corpus Christi, Texas, United States
United States, Wisconsin
Madison, Wisconsin, United States
Sponsors and Collaborators
Daiichi Sankyo, Inc.
More Information

Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00527514     History of Changes
Other Study ID Numbers: 8663-402
First Posted: September 11, 2007    Key Record Dates
Results First Posted: September 23, 2009
Last Update Posted: November 11, 2009
Last Verified: November 2009

Keywords provided by Daiichi Sankyo, Inc.:
Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Stage I and II Hypertension

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