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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00527514
First received: September 10, 2007
Last updated: November 4, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Hypertension
Drug: Amlodipine
Drug: Olmesartan medoxomil plus amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring [ Time Frame: Baseline to 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group. [ Time Frame: Baseline to end of week 3 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group. [ Time Frame: Baseline to end of week 6 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group [ Time Frame: Baseline to end of week 9 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 185
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Amlodipine
Tablets
Drug: Olmesartan medoxomil plus amlodipine
Tablets

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00527514     History of Changes
Other Study ID Numbers: 8663-402
Study First Received: September 10, 2007
Results First Received: May 5, 2009
Last Updated: November 4, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014