8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
15 januari 2014 bijgewerkt door: Novartis Pharmaceuticals
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.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
589
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- Novartis Investigative Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1A 3R5
- Novartis Investigative Site
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Ontario
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Brampton, Ontario, Canada, L6T 0G1
- Novartis Investigative Site
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Toronto, Ontario, Canada, M9W 4L6
- Novartis Investigative Site
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Quebec
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Mirabel, Quebec, Canada, J7J 2K8
- Novartis Investigative Site
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Sainte-Foy, Quebec, Canada, G1W 4R4
- Novartis Investigative Site
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IS
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Pozzilli, IS, Italië, 86077
- Novartis Investigative Site
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PV
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Pavia, PV, Italië, 27100
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SS
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Sassari, SS, Italië, 07100
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Carolina, Puerto Rico, 00983
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Cidra, Puerto Rico, 00739
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Manati, Puerto Rico, 00674
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Bratislava, Slowakije, 821 07
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Martin, Slowakije, 036 01
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Presov, Slowakije, 080 01
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Sala, Slowakije, 927 03
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Zvolen, Slowakije, 960 01
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Slovak Republic
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Kosice, Slovak Republic, Slowakije, 040 11
- Novartis Investigative Site
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Svidnik, Slovak Republic, Slowakije, 08901
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Slovak republic
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Banská Bystrica, Slovak republic, Slowakije, 97405
- Novartis Investigative Site
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Bratislava, Slovak republic, Slowakije, 83299
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Kosice, Slovak republic, Slowakije, 04001
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Nitra, Slovak republic, Slowakije, 95201
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Rimavska Sobota, Slovak republic, Slowakije, 97901
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Senec, Slovak republic, Slowakije, 90301
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Snina, Slovak republic, Slowakije, 09601
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Trnava, Slovak republic, Slowakije, 91701
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Madrid, Spanje, 28009
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Cataluña
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Barcelona, Cataluña, Spanje, 08905
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Centelles, Cataluña, Spanje, 08540
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Corbera de Llobregat, Cataluña, Spanje, 08757
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Hostalets de Balenya, Cataluña, Spanje, 08550
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Vic, Cataluña, Spanje, 08500
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Comunidad Valenciana
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Alzira, Comunidad Valenciana, Spanje, 46600
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Quart de Poblet, Comunidad Valenciana, Spanje, 46930
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Changhua, Taiwan, 500
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Taichung, Taiwan, 40447
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Taipei, Taiwan, 10002
- Novartis Investigative Site
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Taipei, Taiwan, 114
- Novartis Investigative Site
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Taiwan, ROC
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Taipei, Taiwan, ROC, Taiwan, 112
- Novartis Investigative Site
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California
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Los Angeles, California, Verenigde Staten, 90057
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Riverside, California, Verenigde Staten, 92506
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Santa Monica, California, Verenigde Staten, 90404
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Walnut Creek, California, Verenigde Staten, 94598
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Westlake Village, California, Verenigde Staten, 91361
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Florida
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Coral Gables, Florida, Verenigde Staten, 33134
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Miami, Florida, Verenigde Staten, 33169
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South Miami, Florida, Verenigde Staten, 33143
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Illinois
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Chicago, Illinois, Verenigde Staten, 60607
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Chicago, Illinois, Verenigde Staten, 60610
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Indiana
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Evansville, Indiana, Verenigde Staten, 47712
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Kansas
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Topeka, Kansas, Verenigde Staten, 66606
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Louisiana
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Opelousas, Louisiana, Verenigde Staten, 70570
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Minnesota
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Chaska, Minnesota, Verenigde Staten, 55318
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Edina, Minnesota, Verenigde Staten, 55435
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St. Paul, Minnesota, Verenigde Staten, 55114
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Mississippi
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Jackson, Mississippi, Verenigde Staten, 39209
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Picayune, Mississippi, Verenigde Staten, 39466
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Missouri
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St. Louis, Missouri, Verenigde Staten, 63141
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North Carolina
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Charlotte, North Carolina, Verenigde Staten, 28209
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Greensboro, North Carolina, Verenigde Staten, 27401
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Greensboro, North Carolina, Verenigde Staten, 27408
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Salisbury, North Carolina, Verenigde Staten, 28144
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Shelby, North Carolina, Verenigde Staten, 28152
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Winston-Salem, North Carolina, Verenigde Staten, 27103
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45246
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Columbus, Ohio, Verenigde Staten, 43213
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Lyndhurst, Ohio, Verenigde Staten, 44124
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Marion, Ohio, Verenigde Staten, 43302
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Oklahoma
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Norman, Oklahoma, Verenigde Staten, 73069
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Oregon
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Eugene, Oregon, Verenigde Staten, 97404
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Oregon City, Oregon, Verenigde Staten, 97045
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Portland, Oregon, Verenigde Staten, 97239
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Tennessee
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Knoxville, Tennessee, Verenigde Staten, 37920
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Texas
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Beaumont, Texas, Verenigde Staten, 77702
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Houston, Texas, Verenigde Staten, 77081
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Lake Jackson, Texas, Verenigde Staten, 77566
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Pasadena, Texas, Verenigde Staten, 77504
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Utah
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Centerville, Utah, Verenigde Staten, 84104
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Virginia
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Arlington, Virginia, Verenigde Staten, 22203
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Ettrick, Virginia, Verenigde Staten, 23803
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Midlothian, Virginia, Verenigde Staten, 23114
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Washington
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Port Orchard, Washington, Verenigde Staten, 98366
- Novartis Investigative Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
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Aliskiren 300 mg once daily
Andere namen:
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Experimenteel: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
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Aliskiren 300 mg once daily
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
Tijdsspanne: Baseline, week 8
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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.
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Baseline, week 8
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
Tijdsspanne: Baseline, week 8
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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.
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Baseline, week 8
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Percentage of Patients Achieving Blood Pressure Control
Tijdsspanne: 8 weeks
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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
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8 weeks
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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)
Tijdsspanne: Baseline, Week 8
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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.
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Baseline, Week 8
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Percentage of Patients Achieving a Successful Response in Systolic Blood Pressure Reduction
Tijdsspanne: Baseline, Week 8
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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.
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Baseline, Week 8
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Pharmacokinetic (PK) of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration in Fasted vs. Fed
Tijdsspanne: 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)
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Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
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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)
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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
Tijdsspanne: 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)
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Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
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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)
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Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration in Fasted vs. Fed
Tijdsspanne: 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)
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Blood samples were collected at Week 4 and Week 8 in a subset of patients (approximately 15% of each treatment group) for PK analysis.
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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)
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Change From Baseline to Week 8 in Plasma Renin Activity (PRA)
Tijdsspanne: Baseline, Week 8
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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.
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Baseline, Week 8
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Change From Baseline to Week 8 in Plasma Renin Concentration (PRC)
Tijdsspanne: Baseline, Week 8
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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.
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Baseline, Week 8
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Number of Patients With Adverse Events, Serious Adverse Events and Death
Tijdsspanne: 8 weeks
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8 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2012
Primaire voltooiing (Werkelijk)
1 november 2012
Studie voltooiing (Werkelijk)
1 november 2012
Studieregistratiedata
Eerst ingediend
2 april 2012
Eerst ingediend dat voldeed aan de QC-criteria
2 april 2012
Eerst geplaatst (Schatting)
4 april 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
22 januari 2014
Laatste update ingediend die voldeed aan QC-criteria
15 januari 2014
Laatst geverifieerd
1 januari 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CSPP100A2413
- 2011-005297-36 (EudraCT-nummer)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .