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A Study of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Stage I and Stage II Hypertension

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00430638
First received: February 1, 2007
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 278
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Olmesartan medoxomil, plus hydrochlorothiazide, if necessary
Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks
Placebo Comparator: Placebo
Placebo tablets were taken once daily for 12 weeks
Drug: Placebo
Oral tablets administered for once daily for 12 weeks

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.
  Eligibility

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

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.
  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: NCT00430638

  Show 29 Study Locations
Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00430638     History of Changes
Other Study ID Numbers: 866-451
Study First Received: February 1, 2007
Results First Received: October 3, 2008
Last Updated: January 27, 2010
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

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

ClinicalTrials.gov processed this record on November 25, 2014