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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00151775
First received: September 7, 2005
Last updated: May 20, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: olmesartan medoxomil
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dose-ranging Study to Evaluate the Safety and Efficacy of Olmesartan Medoxomil in Children and Adolescents With Hypertension

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks) [ Time Frame: Day 0 to 3 weeks ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks) [ Time Frame: Day 0 (baseline) to 3 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3 [ Time Frame: Week 3 (period 3 baseline) to week 5 (end of Period 3) ] [ Designated as safety issue: No ]
    Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

  • Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3 [ Time Frame: Week 3 (period 3 baseline) to week 5 (end of Period 3) ] [ Designated as safety issue: No ]
    Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.

  • Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) [ Time Frame: Day 0 to week 51 (end of study) ] [ Designated as safety issue: No ]
    Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.

  • Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study) [ Time Frame: Day 0 to week 51 week (end of study) ] [ Designated as safety issue: No ]
    Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.


Enrollment: 362
Study Start Date: May 2005
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period 2

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

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

Other Name: Benicar (olmesartan medoxomil)
Experimental: Period 3
Cohorts A, B, C - olmesartan medoxomil suspension or placebo taken once daily. Olmesartan medoxomil dose continued as in previous period.
Drug: olmesartan medoxomil

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

Other Name: Benicar (olmesartan medoxomil)
Drug: placebo
Cohorts A, B, C: placebo, once daily
Experimental: Period 4

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

Cohorts A and B: Open label olmesartan medoxomil suspension or tablets 10mg - 40 mg. Tablets were used to prepare the suspension or were given directly.

Cohort C: Open label olmesartan medoxomil suspension 0.3 mg/kg - 0.6 mg/kg

Other Name: Benicar (olmesartan medoxomil)

Detailed Description:

This was a randomized, multicenter, double-blind, parallel-group, prospective dose-ranging study in subjects 1 to 16 years of age with hypertension. Subjects were enrolled into 1 of 3 cohorts based on age and race. Subjects 6 to 16 years of age were enrolled into Cohort A. Subjects enrolled into Cohort A were stratified by age with approximately half aged 6 to 12 years and the remainder aged 13 to 16 years. Approximately 15% of the subjects in Cohort A were to be Black or of African descent. When a minimum of 28 Black subjects were randomized into Cohort A, enrollment in Cohort B was started. Black subjects only, 6 to 16 years of age, were enrolled into Cohort B. For Cohorts A and B body weight of any patient was >=20Kg. Seated systolic blood pressure (SeSBP) was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 standard deviations (SD) above the 99th percentile did not participate in the study.

Subjects 1 to 5 years of age were enrolled into Cohort C regardless of race. Body weight of any patient was >=5Kg. SeSBP was >=95th percentile for gender and height-for-age, or >=90th percentile if the patient is diabetic, or has glomerular kidney disease, or has a family history of hypertension. Patients on stable doses of concomitant antihypertensive agents including calcium channel blockers and/or diuretics only are permitted to enroll. Patients with symptomatic hypertension requiring immediate established therapy, or who are above 2 SD above the 99th percentile did not participate in the study.

The study comprised four periods. Period I was a wash-out period from Week -1 to randomization. Subjects were randomized to treatment sequences carried through the remainder of the study. Period II was a three-week, double-blind, dose-ranging period for Cohorts A and B, beginning at Day 1 and ending at the end of Week 3. In Cohorts A and B, subjects received either low-dose or high-dose olmesartan (OM) once daily. In Cohort C, Period II was an open-label OM treatment period where all subjects received 0.3 mg/kg OM per day. Period III was a double-blind, placebo-controlled withdrawal period beginning at Week 4 and ending after 1 or 2 weeks, depending on the seated blood pressure measurement at each weekly study visit. Subjects either continued their Period II OM regimen or switched to placebo based on the initial randomization scheme. Period IV was a 46-week open-label extension period.

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151775

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Sponsors and Collaborators
Daiichi Sankyo Inc.
  More Information

No publications provided

Responsible Party: Michael Melino, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00151775     History of Changes
Other Study ID Numbers: CS0866-A-U301
Study First Received: September 7, 2005
Results First Received: March 8, 2010
Last Updated: May 20, 2010
Health Authority: United States: Food and Drug Administration
India: The Drugs Controller General of India (DCGI)
Kenya: National Council of Science and Technology (NCST)
Republic of South Africa: Medicines Control Council (MCC)
Uganda: National Drug Authority (NDA)
Zambia: Pharmaceutical Regulatory Authority (PRA)
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica (ISP)
Colombia: Instituto Nacional de Vigilancia de Medicamentos y Alimentos (INVIMA)
Costa Rica: Consejo Nacional de Investigacion en Salud (CONIS)

Keywords provided by Daiichi Sankyo Inc.:
Treatment of hypertension or high blood pressure in children ages 1-16 years.

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan medoxomil
Olmesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014