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HypertensionPhase 4NCT01570686

8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension

A Phase 4 study testing Aliskiren in people with Hypertension, run by Novartis Pharmaceuticals at 83 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Aliskiren
Could I receive a placebo?
No, everyone receives an active treatment
How many people
589 participants
Where
83 sitesin 7 countries
Study dates
Apr 2012to Nov 2012
Phase
Phase 4
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with essential hypertension, untreated or currently taking antihypertensive therapy (monotherapy or combination therapy).
  • Patients with an office BP ≥ 140/90 mmHg and < 180/110mmHg at the randomization visit and the preceding visit
  • Patients must have an absolute difference of ≤ 10 mmHg in both their msSBP and their msDBP between the randomization visit and the preceding visit

Who cannot join

  • Malignant hypertension or severe hypertension (grade 3 of WHO classification; msSBP ≥180 mmHg or msDBP ≥110 mmHg)
  • History or evidence of a secondary form of hypertension, such as renal parenchymal hypertension, renovascular hypertension, coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, drug-induced hypertension, unilateral or bilateral renal artery stenosis, pheochromocytoma, polycystic kidney disease (PKD).
  • Type 1 or Type 2 diabetes mellitus with a fasting glycosylated hemoglobin (HbA1c) > 8%
  • Evidence of renal impairment as determined by one of the following: serum creatinine >1.5 x ULN or eGFR < 30 ml/min/1.73m2 at Visit 1, a history of dialysis, or a history of nephrotic syndrome
  • Other protocol-defined inclusion/exclusion criteria may apply.
  • -

Trial locations and contacts

83 sites in 7 countries.

83 sites in 7 countries

United States43 sites

  • Novartis Investigative Site

    Arlington, Virginia, 22203

  • Novartis Investigative Site

    Beaumont, Texas, 77702

  • Novartis Investigative Site

    Centerville, Utah, 84104

  • Novartis Investigative Site

    Charlotte, North Carolina, 28209

  • Novartis Investigative Site

    Chaska, Minnesota, 55318

  • Novartis Investigative Site

    Chicago, Illinois, 60607

  • Novartis Investigative Site

    Chicago, Illinois, 60610

  • Novartis Investigative Site

    Cincinnati, Ohio, 45246

  • Novartis Investigative Site

    Columbus, Ohio, 43213

  • Novartis Investigative Site

    Coral Gables, Florida, 33134

  • Novartis Investigative Site

    Edina, Minnesota, 55435

  • Novartis Investigative Site

    Ettrick, Virginia, 23803

  • Novartis Investigative Site

    Eugene, Oregon, 97404

  • Novartis Investigative Site

    Evansville, Indiana, 47712

  • Novartis Investigative Site

    Greensboro, North Carolina, 27401

  • Novartis Investigative Site

    Greensboro, North Carolina, 27408

  • Novartis Investigative Site

    Houston, Texas, 77081

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Knoxville, Tennessee, 37920

  • Novartis Investigative Site

    Lake Jackson, Texas, 77566

  • Novartis Investigative Site

    Los Angeles, California, 90057

  • Novartis Investigative Site

    Lyndhurst, Ohio, 44124

  • Novartis Investigative Site

    Marion, Ohio, 43302

  • Novartis Investigative Site

    Miami, Florida, 33169

  • Novartis Investigative Site

    Midlothian, Virginia, 23114

  • Novartis Investigative Site

    Norman, Oklahoma, 73069

  • Novartis Investigative Site

    Opelousas, Louisiana, 70570

  • Novartis Investigative Site

    Oregon City, Oregon, 97045

  • Novartis Investigative Site

    Pasadena, Texas, 77504

  • Novartis Investigative Site

    Picayune, Mississippi, 39466

  • Novartis Investigative Site

    Port Orchard, Washington, 98366

  • Novartis Investigative Site

    Portland, Oregon, 97239

  • Novartis Investigative Site

    Riverside, California, 92506

  • Novartis Investigative Site

    Saint Paul, Minnesota, 55114

  • Novartis Investigative Site

    Salisbury, North Carolina, 28144

  • Novartis Investigative Site

    Santa Monica, California, 90404

  • Novartis Investigative Site

    Shelby, North Carolina, 28152

  • Novartis Investigative Site

    South Miami, Florida, 33143

  • Novartis Investigative Site

    St Louis, Missouri, 63141

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative Site

    Walnut Creek, California, 94598

  • Novartis Investigative Site

    Westlake Village, California, 91361

  • Novartis Investigative Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Slovakia15 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovak Republic, 97405

  • Novartis Investigative Site

    Bratislava, Slovak Republic, 83299

  • Novartis Investigative Site

    Bratislava, Slovakia, 821 07

  • Novartis Investigative Site

    Košice, Slovak Republic, 040 11

  • Novartis Investigative Site

    Košice, Slovak Republic, 04001

  • Novartis Investigative Site

    Martin, Slovakia, 036 01

  • Novartis Investigative Site

    Nitra, Slovak Republic, 95201

  • Novartis Investigative Site

    Prešov, Slovakia, 080 01

  • Novartis Investigative Site

    Rimavská Sobota, Slovak Republic, 97901

  • Novartis Investigative Site

    Šaľa, Slovakia, 927 03

  • Novartis Investigative Site

    Senec, Slovak Republic, 90301

  • Novartis Investigative Site

    Snina, Slovak Republic, 09601

  • Novartis Investigative Site

    Svidník, Slovak Republic, 08901

  • Novartis Investigative Site

    Trnava, Slovak Republic, 91701

  • Novartis Investigative Site

    Zvolen, Slovakia, 960 01

Other trials in Slovakia

Spain8 sites

  • Novartis Investigative Site

    Alzira, Valencia, 46600

  • Novartis Investigative Site

    Barcelona, Catalonia, 08905

  • Novartis Investigative Site

    Centelles, Catalonia, 08540

  • Novartis Investigative Site

    Corbera de Llobregat, Catalonia, 08757

  • Novartis Investigative Site

    Hostalets de Balenya, Catalonia, 08550

  • Novartis Investigative Site

    Madrid, Madrid, 28009

  • Novartis Investigative Site

    Quart de Poblet, Valencia, 46930

  • Novartis Investigative Site

    Vic, Catalonia, 08500

Other trials in Spain

Canada6 sites

  • Novartis Investigative Site

    Brampton, Ontario, L6T 0G1

  • Novartis Investigative Site

    Mirabel, Quebec, J7J 2K8

  • Novartis Investigative Site

    Moncton, New Brunswick, E1G 1A7

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1W 4R4

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1A 3R5

  • Novartis Investigative Site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Taiwan5 sites

  • Novartis Investigative Site

    Changhua, 500

  • Novartis Investigative Site

    Taichung, Taiwan, 40447

  • Novartis Investigative Site

    Taipei, Taiwan, 10002

  • Novartis Investigative Site

    Taipei, Taiwan, 114

  • Novartis Investigative Site

    Taipei, Taiwan, ROC, 112

Other trials in Taiwan

Italy3 sites

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pozzilli, IS, 86077

  • Novartis Investigative Site

    Sassari, SS, 07100

Other trials in Italy

Puerto Rico3 sites

  • Novartis Investigative Site

    Carolina, 00983

  • Novartis Investigative Site

    Cidra, 00739

  • Novartis Investigative Site

    Manati, 00674

Other trials in Puerto Rico

About this study

Official title: An 8-week Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of Oral Aliskiren 300 mg Once Daily Under Light Meal Versus Fasted Condition in Patients With Hypertension

The purpose of this study is to evaluate the effect of food on aliskiren's efficacy, pharmacokinetics and safety following an oral dose of 300 mg, given once daily under light meal versus fasted conditions.

Conditions
Hypertension
Being tested
Aliskiren
Keywords
Food effect, hypertension, aliskiren
Medical subject headings
Hypertension

What participants receive

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

  • AliskirenDrug

    Also called Tekturna, rasilez

    Aliskiren 300 mg once daily

Study groups in NCT01570686
Study groupRoleWhat they receive
Aliskiren: FedExperimentalAliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
Receives: Drug: Aliskiren
Aliskiren: FastingExperimentalAliskiren 300 mg once daily taken after after an overnight fast
Receives: Drug: Aliskiren

What is being measured

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

  1. Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)

    24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maSBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.

    Measured: Baseline, week 8

Secondary outcomes (10)

  1. Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)

    24 hour ambulatory blood pressure measurement (ABPM) were taken twice, at baseline and at the end of 8 weeks. An Ambulatory Blood Pressure Monitoring device (ABPM) was attached to the non-dominant arm. The mean change of 24 hours maDBP from baseline to week 8 was estimated using an Analysis of Covariance (ANCOVA) model by using treatment, region as factors, and baseline as covariate.

    Measured: Baseline, week 8

  2. Percentage of Patients Achieving Blood Pressure Control

    Patients achieving blood pressure control were patients who, at week 8, had a mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) < 140/90 mmHg

    Measured: 8 weeks

  3. Change From Baseline (Visit 3) to End of Study (8 Weeks) in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

    Sitting blood pressure (BP) was measured at trough (approximately 24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the BP was checked in both arms and the arm with higher systolic BP (SBP) was used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures (msSBP and msDBP) were measured four times using a standard mercury sphygmomanometer and appropriate size cuff. The repeat sitting measurements were made at 2 minute intervals and the mean of all four sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. The analysis of covariance (ANCOVA) model used treatment, region as factors, and baseline as covariate.

    Measured: Baseline, Week 8

  4. Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction

    Successful response in systolic blood pressure reduction at end of 8-week treatment was defined as msSBP <140 mmHg or a reduction in msSBP ≥ 20 mmHg from baseline.

    Measured: Baseline, Week 8

  5. Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed

    Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.

    Measured: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)

  6. Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) in Fasted vs. Fed

    Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.

    Measured: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)

  7. Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed

    Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.

    Measured: Week 4 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose) and week 8 (0, 0.5, 1, 1.5, 2, 4, 6 and 24 hrs post-dose)

  8. Change From Baseline to Week 8 in Plasma Renin Activity (PRA)

    Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin activity (PRA) . Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8).The difference between baseline and week 8 was calculated.

    Measured: Baseline, Week 8

  9. Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)

    Biomarkers related to hypertension-related pathophysiology were evaluated in this study, such as plasma renin concentration (PRC). Blood samples were taken at Visit 3 (baseline) and Visit 6 (week 8). The difference between baseline and week 8 was calculated.

    Measured: Baseline, Week 8

  10. Number of Patients With Adverse Events, Serious Adverse Events and Death

    Measured: 8 weeks

Timeline

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

  1. First posted4 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionNov 2012
  4. Study completionNov 2012

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
589 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01570686
Sponsor's protocol ID
CSPP100A2413
Other IDs
2011-005297-36
Status last verified
Jan 2014
First submitted
2 Apr 2012
Last updated
22 Jan 2014

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aliskiren in people with Hypertension, run by Novartis Pharmaceuticals at 83 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 3 inclusion and 6 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 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 83 sites in United States, Slovakia, Spain, Canada, Taiwan 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 1 Jan 2014). 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 (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP) (time frame: Baseline, week 8). 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 NCT01570686.

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 22 Jan 2014.

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