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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00403481
First received: November 22, 2006
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: olmesartan medoxomil
Drug: Olmesartan medoxomil plus Hydrochlorothiazide
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM. [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic). [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: November 2006
Study Completion Date: December 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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
  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: NCT00403481

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

No publications provided by Daiichi Sankyo Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00403481     History of Changes
Other Study ID Numbers: 866-449
Study First Received: November 22, 2006
Results First Received: November 21, 2008
Last Updated: November 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
Hypertension
Angiotensin Receptor Blocker
Calcium Channel Blocker
Angiotensin Converting Enzyme Inhibitor
Hydrochlorothiazide
Stage I and II Hypertension
Type II Diabetes

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Olmesartan medoxomil
Hydrochlorothiazide
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014