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A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in 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: NCT00430638
Recruitment Status : Completed
First Posted : February 2, 2007
Results First Posted : January 22, 2010
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Tracking Information
First Submitted Date  ICMJE February 1, 2007
First Posted Date  ICMJE February 2, 2007
Results First Submitted Date  ICMJE October 3, 2008
Results First Posted Date  ICMJE January 22, 2010
Last Update Posted Date October 2, 2018
Study Start Date  ICMJE December 2006
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. [ Time Frame: baseline to 12 weeks ]
The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group.
Original Primary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
  • Change from baseline in mean Systolic BP (SBP) after 12 weeks of randomized
  • treatment as measured by Omron device.
Change History Complete list of historical versions of study NCT00430638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2018)
  • Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. [ Time Frame: baseline to 12 weeks ]
    Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach.
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males. [ Time Frame: Baseline to week 12 ]
    The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed.
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females. [ Time Frame: Baseline to week 12 ]
    The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed.
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old. [ Time Frame: Baseline to 12 weeks ]
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old. [ Time Frame: Baseline to 12 weeks ]
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants. [ Time Frame: Baseline to week 12 ]
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants. [ Time Frame: Baseline to 12 weeks ]
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives [ Time Frame: Baseline to 12 weeks ]
  • The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives [ Time Frame: Baseline to 12 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2007)
  • Change from baseline in mean Diastolic BP (DBP) after 12 weeks of randomized
  • treatment as measured by Omron device.
  • Change from baseline in mean SBP and DBP at each titration step as measured by
  • Omron device.
  • Incremental cuff BP change between each titration step.
  • The percentage of patients achieving cuff BP goals of: SBP <140, <130, <120
  • mmHg; DBP <9-, <85, <80 mmHg and BP <140/90, <130/85, <130/80 and <120/80 mmHg
  • at each titration period and at end of study.
  • Number and percentage of patients achieving DBP drop in the following
  • categories: drop less than or equal to15 mmHg; 15 <drop less than or equal to
  • 30 mmHg; 30 <drop less than or equal to 45 mmHg; drop > 45 mmHg.
  • categories: drop less than or equal to 10 mmHg; 10 <drop less than or equal to
  • 15 mmHg; 15 <drop less than or equal to 20 mmHg; drop > 20 mmHg.
  • Subgroup analyses by age group (<65 yrs and greater than or equal to 65 yrs),
  • race group (Black and Non-Black), gender group (Male and Female), and baseline
  • cuff BP stage (Stages 1 and 2), respectively, on all of the aforementioned
  • variables, as appropriate.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension
Official Title  ICMJE A Double-Blind, Randomized, Placebo Controlled, Parallel Group Study to Compare the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension
Brief Summary This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
Detailed Description

This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

  • First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
  • Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo
  • Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo
  • Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo
  • Subjects with a mean BP of <120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.
  • Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.
  • Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
    olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
  • Drug: Placebo
    Oral tablets administered for once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: Treatment
    Olmesartan medoxomil, plus hydrochlorothiazide, if necessary
    Intervention: Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
  • Placebo Comparator: Placebo
    Placebo tablets were taken once daily for 12 weeks
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2009)
278
Original Enrollment  ICMJE
 (submitted: February 1, 2007)
250
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Greater than or equal to 18 years of age.
  • Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 140 mmHg but less than or equal to 179 mmHg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 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) systolic blood pressure (SBP) greater than or equal to 135 mmHg and less than or equal to 179 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg 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 (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 first, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00430638
Other Study ID Numbers  ICMJE 866-451
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daiichi Sankyo, Inc.
Study Sponsor  ICMJE Daiichi Sankyo, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Daiichi Sankyo, Inc.
Verification Date September 2018

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