Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure

NCT00151775 | Completed Phase 2 Results

• 1 other identifier: CS0866-A-U301
• Study Type: interventional
• Target: 362
• Locations: 10 countries
• Sites: 55

Brief Summary

This study assesses the efficacy and safety of olmesartan medoxomil in children ages 1-16 with high blood pressure. After a 5-week blinded treatment period of up to 5 weeks participants can continue to take olmesartan medoxomil (OM) for up to an additional 46 weeks.

Conditions

Hypertension

Keywords

Treatment of hypertension or high blood pressure in children ages 1-16 years.

Outcome Measures

Primary Outcomes (2)

• Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)

  The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.

  Day 0 to 3 weeks

• Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)

  Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

  Day 0 (baseline) to 3 weeks

Secondary Outcomes (4)

• Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

  Week 3 (period 3 baseline) to week 5 (end of Period 3)

• Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3

  Week 3 (period 3 baseline) to week 5 (end of Period 3)

• Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

  Day 0 to week 51 (end of study)

• Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)

  Day 0 to week 51 week (end of study)

Study Arms (3)

Period 2

EXPERIMENTAL

For Cohorts A and B, olmesartan medoxomil suspension 2.5 mg to 40 mg in patients 6-16 years old, depending on weight. For Cohort C, olmesartan medoxomil suspension 0.3 mg/kg to in patients 1-5 years old.

Drug: olmesartan medoxomil

Period 3

EXPERIMENTAL

Cohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily. Olmesartan medoxomil dose continued as in previous period.

Drug: olmesartan medoxomil; Drug: placebo

Period 4

EXPERIMENTAL

Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg

Drug: olmesartan medoxomil

Interventions

olmesartan medoxomil DRUG

Cohorts A and B: 2.5mg to 40mg olmesartan, as a suspension (depending on weight), once daily. Tablets were used to prepare a suspension. Cohort C: 0.3mg/kg olmesartan ,as a suspension, once daily

Also known as: Benicar (olmesartan medoxomil)

Period 2; Period 3

placebo DRUG

Cohorts A, B, C: placebo, once daily

Period 3

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The patient's seated systolic BP (SeSBP) will be greater than or equal to 95th percentile for gender and height-for- age, or greater than or equal to 90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension.
• Negative for hepatitis B and C
• Negative for HIV

You may not qualify if:

• Patient should not have serious other conditions that could interfere with the analysis of the results or that could interfere with the well-being of the patient in the trial.
• Known sensitivity to olmesartan medoxomil
• Taking prohibited medication
• Consumed greater than 180 mg of caffeine daily
• Malignant hypertension
• History of congestive heart failure, cardiomyopathy, or obstructive valve disease
• Renal transplant within the previous 6 months
• Severe nephritic syndrome not in remission

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (65)

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Birmingham, Alabama, United States

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Phoenix, Arizona, 85013, United States

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Little Rock, Arkansas, United States

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Beverly Hills, California, United States

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Fresno, California, United States

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Los Angeles, California, 90049, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Tampa, Florida, 33647, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Park Ridge, Illinois, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Grand Rapids, Michigan, United States

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Las Vegas, Nevada, United States

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Hackensack, New Jersey, United States

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New Brunswick, New Jersey, United States

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Kinston, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Portland, Oregon, United States

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Beaumont, Texas, United States

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Houston, Texas, United States

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Charlottesville, Virginia, United States

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San Miguel de Tucumán, TUC, Argentina

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Bahía Blanca, Argentina

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Buenos Aires, Argentina

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Capital Federal, Argentina

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Mar del Plata, Argentina

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Campinas, Brazil

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Curitiba, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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São Paulo, Brazil

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Santiago, Chile

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Bogotá, Colombia

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Cali-Valle, Colombia

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Ahmedabad, Gujarat, India

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Mangalore, Karna, India

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Vellore, Karna, India

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Trivandrum, Kerala, India

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Lucknow, Uttar Prad, India

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Chandigarh, India

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Hyderabad, 500 033, India

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New Delhi, 110 029, India

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Tamil Nadu, India

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Nairobi, Kenya

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Lima, Peru

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Bloemfontein, 9300, South Africa

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Cape Town, 7764, South Africa

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Durban, KZ-Natal, South Africa

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E Cape, South Africa

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Eastern Cape, 5200, South Africa

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Park Town, Gauteng, South Africa

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Pietermaritzburg, KZ-Natal, South Africa

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Potchefstroom, Northwest, South Africa

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Pretoria, Gauteng, South Africa

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Western Cape, 7130, South Africa

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Kampala, Uganda

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Kitwe, Zambia

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Lusaka, Zambia

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MeSH Terms

Conditions

Hypertension

Interventions

Olmesartan Medoxomil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Results Point of Contact

• Title: Howard Kessler, Senior Director Regulatory Operations
• Organization: Daiichi Sankyo

hmkessler@dsi.com

732-590-5032

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: May 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 30, 2016
• Results First Posted: April 2, 2010

Record last verified: 2016-05

Locations

UG (1); AR (5); BR (5); CO (2); PE (1); US (28); IN (9); KE (1); CL (1); ZA (2)