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OpenTrials
Completed

NCT Number: NCT00791258

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

amlodipine and olmesartan medoxomil tablets

Drug

amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks

Other names: AZOR Tablets

hydrochlorothiazide tablets

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Integrium

Registry information

Official study 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

Acronym: BP CRUSH

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 14, 2008
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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