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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)

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: NCT00791258
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : September 29, 2010
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
Integrium
Information provided by:
Daiichi Sankyo, Inc.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: amlodipine and olmesartan medoxomil tablets Drug: hydrochlorothiazide tablets Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 999 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2008
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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
Other Name: AZOR Tablets

Drug: hydrochlorothiazide tablets
hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks [ Time Frame: baseline to 12 weeks ]

Secondary Outcome Measures :
  1. The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks [ Time Frame: baseline to 12 weeks ]
  2. The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks [ Time Frame: Baseline to 12 and 20 weeks ]
  3. Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  4. Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  5. Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  6. Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  7. Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  8. Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  9. Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  10. Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

  11. Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM.

  12. Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m.

  13. Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m.

  14. Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

  15. Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours.

  16. Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values [ Time Frame: Baseline to 12 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

  17. Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values [ Time Frame: Baseline to 20 weeks ]
    Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m.

  18. Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  19. Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  20. Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  21. Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  22. Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  23. Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  24. Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  25. Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  26. Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  27. Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  28. Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  29. Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  30. Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  31. Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  32. Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  33. Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  34. Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  35. Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  36. Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  37. Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  38. Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  39. Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  40. Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  41. Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  42. Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  43. Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  44. Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  45. Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  46. Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks [ Time Frame: Baseline to 4, 8, 12, 16, 20 weeks ]
  47. Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
  48. Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
  49. Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
  50. Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
  51. Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
  52. Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
  53. Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
  54. Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
  55. Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
  56. Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]
  57. Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks [ Time Frame: Baseline to 12 weeks ]
  58. Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks [ Time Frame: Baseline to 20 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791258


Locations
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Sponsors and Collaborators
Daiichi Sankyo, Inc.
Integrium
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Diector of Medical Research and Strategy, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00791258    
Other Study ID Numbers: CS8663-404
First Posted: November 14, 2008    Key Record Dates
Results First Posted: September 29, 2010
Last Update Posted: January 9, 2019
Last Verified: September 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Hydrochlorothiazide
Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists