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A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure (BP CRUSH)
This study is not yet open for participant recruitment.
Verified by Daiichi Sankyo Inc., November 2008
Sponsors and Collaborators: Daiichi Sankyo Inc.
Integrium
Information provided by: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00791258
  Purpose

The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.


Condition Intervention Phase
Hypertension
 Drug: amlodipine and olmesartan medoxomil tablets
Drug: hydrochlorothiazide tablets
 Phase IV

MedlinePlus related topics: High Blood Pressure
Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Olmesartan Olmesartan medoxomil
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • The percent of patients who achieve cuff systolic blood pressure goal (<140 mm Hg for non-diabetics and <130 mm Hg for diabetics) during the dual combination period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The percentage of subjects achieving cuff diastolic BP goal (<90 mmHg for non-diabetics or < 80 mmHg for subjects with diabetes) during the dual-combination period [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The percentage of subjects who achieve cuff BP goal (<140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The percentage of subjects who achieve cuff BP goal (<140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean cuff systolic BP [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in mean cuff diastolic BP [ Time Frame: 4,8,12,16,20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Systolic BP goal of <140 mm HG [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Systolic BP goal of <135 mm HG [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Systolic BP goal of <130 mm HG [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Systolic BP goal of <120 mm HG [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Diastolic BP goal of <90 mm HG [ Time Frame: 4, 8, 12,16,20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Diastolic BP goal of <85 mm HG [ Time Frame: 4, 8, 12,16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff Diastolic BP goal of <80 mm HG [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <140/90 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <135/85 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <130/80 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <120/80 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff systolic BP drop of <= to 15 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff systolic BP drop of < 15 mm Hg to <= 30 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff systolic BP drop of < 30 mm Hg to <= 45 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff systolic BP drop of > 45 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff diastolic BP drop of <= 10 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff diastolic BP drop of <10 to <= 15 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff diastolic BP drop of <15 to <= 20 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]
  • Number and percentage of patients achieving cuff diastolic BP drop of >20 mm Hg [ Time Frame: 4, 8, 12, 16, 20 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks
Drug: amlodipine and olmesartan medoxomil tablets
amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks
Drug: hydrochlorothiazide tablets
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks

  Eligibility

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

Inclusion Criteria:

  • >= to 18 years of age
  • Hypertension uncontrolled on current monotherapy
  • Females:
  • negative serum pregnancy test at screening
  • post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control

Exclusion Criteria:

  • Pregnant females
  • Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
  • Diabetes requiring insulin
  • Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
  • History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
  • History of Class III or IV congestive heart failure
  • History of stroke or transient ischemic attack within the last 1 year
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791258

Contacts
Contact: Julie B Tobin 623-271-9334 julie.tobin@integrium.com

Sponsors and Collaborators
Daiichi Sankyo Inc.
Integrium
  More Information

Responsible Party: Daiichi Sankyo ( Diector of Medical Research and Strategy )
Study ID Numbers: CS8663-404
Study First Received: November 13, 2008
Last Updated: November 21, 2008
ClinicalTrials.gov Identifier: NCT00791258  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Calcium, Dietary
Vascular Diseases
Olmesartan medoxomil
Angiotensin II
 Hydrochlorothiazide
Amlodipine
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Calcium Channel Blockers
Cardiovascular Agents
 Antihypertensive Agents
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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