Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age

NCT01150357 | Completed Phase 3 Results

• 2 other identifiers: CSPP100A23652009-017028-22
• Study Type: interventional
• Target: 267
• Locations: 9 countries
• Sites: 48

Brief Summary

This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.

Conditions

Hypertension

Keywords

Pediatric hypertension; primary hypertension; secondary hypertension

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)

  Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.

  Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))

• Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)

  Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.

  Week 4 to endpoint (Week 8 or LOCF)

Secondary Outcomes (11)

• Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)

  Baseline up to Week 4

• Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)

  From Week 4 to Week 8

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)

  Baseline to endpoint (Week 4 or LOCF)

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)

  Week 4 to endpoint (Week 8 or LOCF)

• Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)

  Baseline to endpoint (Week 4 or LOCF)

Study Arms (3)

Low Dose Aliskiren

EXPERIMENTAL

Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than \< 50 kg received 6.25 mg; ≥50 kg and \< 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.

Drug: Aliskiren (6.25/12.5/25 mg)

Mid dose

EXPERIMENTAL

Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 37.5 mg; ≥50 kg and \< 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.

Drug: Aliskiren (37.5/75/150 mg)

High dose

EXPERIMENTAL

Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to \< 50 kg received 150 mg; ≥50 kg and \< 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.

Drug: Aliskiren (150/300/600 mg)

Interventions

Aliskiren (6.25/12.5/25 mg) DRUG

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.

Low Dose Aliskiren

Aliskiren (37.5/75/150 mg) DRUG

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.

Mid dose

Aliskiren (150/300/600 mg) DRUG

Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.

High dose

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
• msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004

You may not qualify if:

• Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
• Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
• msSBP ≥ 25% above the 95th percentile
• Second or third degree heart block without a pacemaker
• AST/SGOT or ALT/SGPT \>3 times the upper limit of the reference range
• Total bilirubin \> 2 times the upper limit of the reference range
• Creatinine clearance \< 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate \[GFR\]), based on the serum creatinine concentration obtained at the screening visit)
• WBC count \< 3000/mm³

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (48)

Novartis Investigative Site

Birmingham, Alabama, 35294-0006, United States

Location

Novartis Investigative Site

Little Rock, Arkansas, 72202, United States

Location

Novartis Investigative Site

Los Angeles, California, 90048, United States

Location

Novartis Investigative Site

San Diego, California, 92123, United States

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Novartis Investigative Site

Pensacola, Florida, 32504, United States

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Novartis Investigative Site

Atlanta, Georgia, 30322, United States

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Novartis Investigative Site

Dalton, Georgia, 30721, United States

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Novartis Investigative Site

Lewiston, Idaho, 83501, United States

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Novartis Investigative Site

Park Ridge, Illinois, 60068, United States

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Novartis Investigative Site

Louisville, Kentucky, 40202, United States

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Novartis Investigative Site

Hattiesburg, Mississippi, 39401, United States

Location

Novartis Investigative Site

Jackson, Mississippi, 39209, United States

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Novartis Investigative Site

Hackensack, New Jersey, 07601, United States

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Novartis Investigative Site

New York, New York, 10016, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43205, United States

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Novartis Investigative Site

Toledo, Ohio, 43606, United States

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Novartis Investigative Site

Portland, Oregon, 97225, United States

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Novartis Investigative Site

Portland, Oregon, 97239, United States

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Novartis Investigative Site

Pittsburgh, Pennsylvania, 15224, United States

Location

Novartis Investigative Site

Charleston, South Carolina, 29425, United States

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Novartis Investigative Site

Amarillo, Texas, 79106, United States

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Novartis Investigative Site

Seattle, Washington, 98105, United States

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Novartis Investigative Site

Charleston, West Virginia, 25304, United States

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Novartis Investigative Site

Brussels, 1090, Belgium

Location

Novartis Investigative Site

Edegem, 2650, Belgium

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Novartis Investigative Site

Ghent, 9000, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Marburg, 35039, Germany

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Novartis Investigative Site

Guatemala City, Departamento de Guatemala, 01010, Guatemala

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Novartis Investigative Site

Nyíregyháza, Hungary, 4400, Hungary

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Novartis Investigative Site

Szeged, Hungary, 6725, Hungary

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Novartis Investigative Site

Budapest, 1083, Hungary

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Novartis Investigative Site

Budapest, 1131, Hungary

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Novartis Investigative Site

Debrecen, 4032, Hungary

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Novartis Investigative Site

Miskolc, 3529, Hungary

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Novartis Investigative Site

Veszprém, H-8200, Hungary

Location

Novartis Investigative Site

Warsaw, 04-154, Poland

Location

Novartis Investigative Site

San Juan, 00907, Puerto Rico

Location

Novartis Investigative Site

Bratislava, Slovakia, 84103, Slovakia

Location

Novartis Investigative Site

Bratislava, Slovakia, 85107, Slovakia

Location

Novartis Investigative Site

Martin, Slovakia, 03601, Slovakia

Location

Novartis Investigative Site

Myjava, Slovakia, 90701, Slovakia

Location

Novartis Investigative Site

Prešov, Slovakia, 08001, Slovakia

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Novartis Investigative Site

Trnava, Slovakia, 91701, Slovakia

Location

Novartis Investigative Site

Ankara, Turkey, 06100, Turkey (Türkiye)

Location

Novartis Investigative Site

Ankara, Turkey, 06490, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Turkey, 06500, Turkey (Türkiye)

Location

Novartis Investigative Site

Izmir, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 -778 -8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 15, 2015
• Results First Posted: October 15, 2015

Record last verified: 2015-09

Locations

DE (1); TU (4); HU (7); US (23); BE (4); GU (1); PL (1); PR (1); SL (6)