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

NCT00791258 | Completed Phase 4 Results

• 1 other identifier: CS8663-404
• Study Type: interventional
• Target: 999
• Locations: 1 country
• Sites: 72

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.

Conditions

Hypertension

Outcome Measures

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

  baseline to 12 weeks

Secondary Outcomes (58)

• 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

  baseline to 12 weeks

• 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

  Baseline to 12 and 20 weeks

• Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

  Baseline to 4, 8, 12, 16, 20 weeks

• Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

  Baseline to 4, 8, 12, 16, 20 weeks

• Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

  Baseline to 4, 8, 12, 16, 20 weeks

Study Arms (1)

1

EXPERIMENTAL

Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks

Drug: amlodipine and olmesartan medoxomil tablets; Drug: hydrochlorothiazide tablets

Interventions

amlodipine and olmesartan medoxomil tablets DRUG

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

Also known as: AZOR Tablets

1

hydrochlorothiazide tablets DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Integrium: collaborator

Study Sites (72)

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Birmingham, Alabama, United States

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Green Valley, Arizona, United States

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Mesa, Arizona, United States

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Sierra Vista, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Harbor City, California, United States

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National City, California, United States

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Tustin, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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Pueblo, Colorado, United States

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Milford, Connecticut, United States

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Boynton Beach, Florida, United States

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Brooksville, Florida, United States

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Clearwater, Florida, United States

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Deerfield Beach, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Kissimmee, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Boise, Idaho, United States

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Addison, Illinois, United States

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Orland Park, Illinois, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Columbia, Maryland, United States

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Elkridge, Maryland, United States

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Oxon Hill, Maryland, United States

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Reisterstown, Maryland, United States

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Stevensville, Michigan, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Edison, New Jersey, United States

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Sewell, New Jersey, United States

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Albuquerque, New Mexico, United States

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Binghamton, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Harrisburg, North Carolina, United States

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Hickory, North Carolina, United States

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High Point, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Havertown, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greenville, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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New Tazewell, Tennessee, United States

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Amarillo, Texas, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Longview, Texas, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Walla Walla, Washington, United States

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Madison, Wisconsin, United States

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Related Publications (2)

• Nesbitt SD, Shojaee A, Maa JF, Weir MR. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens. 2013 Jul;27(7):445-52. doi: 10.1038/jhh.2012.65. Epub 2012 Dec 20.

  PMID: 23254596 DERIVED

• Hsueh WA, Shojaee A, Maa JF, Neutel JM. Efficacy of amlodipine/olmesartan medoxomil +/- HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Curr Med Res Opin. 2012 Nov;28(11):1809-18. doi: 10.1185/03007995.2012.740632. Epub 2012 Oct 30.

  PMID: 23072496 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Olmesartan Medoxomil; Amlodipine Besylate, Olmesartan Medoxomil Drug Combination; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Tetrazoles; Drug Combinations; Pharmaceutical Preparations; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: John Raia
• Organization: Daiichi Sankyo, Inc

jraia@dsi.com

(973) 944-2683

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 14, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 9, 2019
• Results First Posted: September 29, 2010

Record last verified: 2010-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (72)