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

November 22, 2006
November 9, 2009
November 2006
November 2007   (final data collection date for primary outcome measure)
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 ]
Change from baseline in Systolic BP (SBP) after 12 weeks of active treatment as measured by 24-hour ABPM.
Complete list of historical versions of study NCT00403481 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change from baseline in mean 24-hr ABPM Diastolic BP (DBP) after 12 weeks active treatment.
  • Percentage of patients achieving mean 24-hr, daytime, nighttime, last 2,4,6-hr ABPM BP goals: SBP<140;<135;<130;<125;<120mmHg; DBP<90;<85;<80;<75mmHg; BP<140/90;<135/85;<130/80;<120/80 and <125/75mmHg at end of study.
Not Provided
Not Provided
 
An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • Drug: olmesartan medoxomil
    Olmesartan medoxomil tablets, once daily
  • Drug: Olmesartan medoxomil plus Hydrochlorothiazide
    Olmesartan medoxomil and hydrochlorothiazide combination tablets, once daily, if necessary
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.
Interventions:
  • Drug: olmesartan medoxomil
  • Drug: Olmesartan medoxomil plus Hydrochlorothiazide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
192
December 2007
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00403481
866-449
Not Provided
William Waverczak, Daiichi Sankyo
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP