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HypertensionPhase 3NCT01151410

An Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

A Phase 3 study testing Aliskiren and Enalapril in people with Hypertension, run by Novartis Pharmaceuticals at 36 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study… Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Hypertension
What is being tested?
Aliskiren and Enalapril
Could I receive a placebo?
No, everyone receives an active treatment
How many people
208 participants
Where
36 sitesin 7 countries
Study dates
Aug 2010to Aug 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • msSBP (mean of 3 systolic blood pressure measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization), in study CSPP100A2365
  • Must be ≥ 20 kg and ≤ 150 kg at Visit 2 (randomization), in study CSPP100A2365
  • Must be able to swallow minitablets (2mm in diameter) administered in soft food
  • Successful completion of Phase 1 (dose response phase) and at least 1 week of Phase 2 (placebo withdrawal phase) of the CSPP100A2365 protocol, with no serious drug-related adverse event(s).

Who cannot join

  • 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
Show all 11Show fewer
  • 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
  • Platelet count < 100,000/mm³
  • Serum potassium > 5.2 mEq/L
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

36 sites in 7 countries.

36 sites in 7 countries

United States17 sites

  • Novartis Investigative Site

    Amarillo, Texas, 79106

  • Novartis Investigative Site

    Birmingham, Alabama, 35294-0006

  • Novartis Investigative Site

    Charleston, South Carolina, 29425

  • Novartis Investigative Site

    Charleston, West Virginia, 25304

  • Novartis Investigative Site

    Columbus, Ohio, 43205

  • Novartis Investigative Site

    Dalton, Georgia, 30721

  • Novartis Investigative Site

    Hattiesburg, Mississippi, 39401

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Lewiston, Idaho, 83501

  • Novartis Investigative Site

    Little Rock, Arkansas, 72202

  • Novartis Investigative Site

    Los Angeles, California, 90048

  • Novartis Investigative Site

    Louisville, Kentucky, 40202

  • Novartis Investigative Site

    New York, New York, 10016

  • Novartis Investigative Site

    Park Ridge, Illinois, 60068

  • Novartis Investigative Site

    Portland, Oregon, 07227

  • Novartis Investigative Site

    Portland, Oregon, 97225

  • Novartis Investigative Site

    Toledo, Ohio, 43606

Other trials in United States

Hungary7 sites

  • Novartis Investigative Site

    Budapest, 1083

  • Novartis Investigative Site

    Budapest, 1131

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Miskolc, 3529

  • Novartis Investigative Site

    Nyíregyháza, Hungary, 4400

  • Novartis Investigative Site

    Szeged, Hungary, 6725

  • Novartis Investigative Site

    Veszprém, H-8200

Other trials in Hungary

Slovakia6 sites

  • Novartis Investigative Site

    Bratislava, Slovakia, 84103

  • Novartis Investigative Site

    Bratislava, Slovakia, 85107

  • Novartis Investigative Site

    Martin, Slovakia, 03601

  • Novartis Investigative Site

    Myjava, Slovakia, 90701

  • Novartis Investigative Site

    Prešov, Slovakia, 08001

  • Novartis Investigative Site

    Trnava, Slovakia, 91701

Other trials in Slovakia

Turkey (Türkiye)3 sites

  • Novartis Investigative Site

    Ankara, Turkey, 06100

  • Novartis Investigative Site

    Ankara, Turkey, 06490

  • Novartis Investigative Site

    Ankara, Turkey, 06500

Other trials in Turkey (Türkiye)

Guatemala1 site

  • Novartis Investigative Site

    Guatemala City, Departamento de Guatemala, 01010

Other trials in Guatemala

Poland1 site

  • Novartis Investigative Site

    Warsaw, 04-154

Other trials in Poland

Puerto Rico1 site

  • Novartis Investigative Site

    San Juan, 00907

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Double-blind, Randomized, 52-week, Extension Study to Evaluate the Long Term Safety, Tolerability and Efficacy of Aliskiren Compared to Enalapril in Pediatric Hypertensive Patients 6-17 Years of Age

The purpose of this study is to evaluate in a randomized, double-blind fashion, the long-term safety, tolerability and efficacy profile of aliskiren compared to the active comparator enalapril in children, 6 - 17 years old with hypertension (msSBP ≥ 95th percentile for age, gender and height, at baseline in study CSPP100A2365). Patients will be randomized to receive either aliskiren or enalapril. Weight-group based doses of aliskiren or enalapril will be administered once daily and children will receive study medication in a double-blind manner. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in pediatric patients 6-17 years of age (age at baseline in Study CSPP100A2365).

Conditions
Hypertension
Being tested
Aliskiren, Enalapril
Keywords
Pediatric hypertension, primary hypertension, secondary, hypertension
Medical subject headings
Hypertension, Essential Hypertension, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AliskirenDrug

    Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg

    Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg

    High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg

  • EnalaprilDrug

    Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg

    Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg

    High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg

Study groups in NCT01151410
Study groupRoleWhat they receive
AliskirenExperimentalPatients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
Receives: Drug: Aliskiren
EnalaprilActive comparatorPatients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
Receives: Drug: Enalapril

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study

    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 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.

    Measured: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)

Secondary outcomes (2)

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study

    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 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.

    Measured: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)

  2. Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study

    MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP).

    Measured: Baseline to end of study (Week 52 or LOCF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01151410
Sponsor's protocol ID
CSPP100A2365E1
Other IDs
2009-017029-20, 2009
Status last verified
Jan 2016
First submitted
23 Jun 2010
Last updated
7 Mar 2016

Publications

  • Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

    PubMed 33089502

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren and Enalapril in people with Hypertension, run by Novartis Pharmaceuticals at 36 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in United States, Hungary, Slovakia, Turkey (Türkiye), Guatemala and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study (time frame: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01151410, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.

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Clinical Trial NCT01151410 | AzTrials