8-week Randomized, Open-label Study to Evaluate Food Effect on Efficacy and Safety of Oral Aliskiren 300 mg in Patients With Hypertension
2014년 1월 15일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
589
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Changhua, 대만, 500
- Novartis Investigative Site
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Taichung, 대만, 40447
- Novartis Investigative Site
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Taipei, 대만, 10002
- Novartis Investigative Site
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Taipei, 대만, 114
- Novartis Investigative Site
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Taiwan, ROC
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Taipei, Taiwan, ROC, 대만, 112
- Novartis Investigative Site
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California
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Los Angeles, California, 미국, 90057
- Novartis Investigative Site
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Riverside, California, 미국, 92506
- Novartis Investigative Site
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Santa Monica, California, 미국, 90404
- Novartis Investigative Site
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Walnut Creek, California, 미국, 94598
- Novartis Investigative Site
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Westlake Village, California, 미국, 91361
- Novartis Investigative Site
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Florida
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Coral Gables, Florida, 미국, 33134
- Novartis Investigative Site
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Miami, Florida, 미국, 33169
- Novartis Investigative Site
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South Miami, Florida, 미국, 33143
- Novartis Investigative Site
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Illinois
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Chicago, Illinois, 미국, 60607
- Novartis Investigative Site
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Chicago, Illinois, 미국, 60610
- Novartis Investigative Site
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Indiana
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Evansville, Indiana, 미국, 47712
- Novartis Investigative Site
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Kansas
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Topeka, Kansas, 미국, 66606
- Novartis Investigative Site
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Louisiana
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Opelousas, Louisiana, 미국, 70570
- Novartis Investigative Site
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Minnesota
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Chaska, Minnesota, 미국, 55318
- Novartis Investigative Site
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Edina, Minnesota, 미국, 55435
- Novartis Investigative Site
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St. Paul, Minnesota, 미국, 55114
- Novartis Investigative Site
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Mississippi
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Jackson, Mississippi, 미국, 39209
- Novartis Investigative Site
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Picayune, Mississippi, 미국, 39466
- Novartis Investigative Site
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Missouri
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St. Louis, Missouri, 미국, 63141
- Novartis Investigative Site
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North Carolina
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Charlotte, North Carolina, 미국, 28209
- Novartis Investigative Site
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Greensboro, North Carolina, 미국, 27401
- Novartis Investigative Site
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Greensboro, North Carolina, 미국, 27408
- Novartis Investigative Site
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Salisbury, North Carolina, 미국, 28144
- Novartis Investigative Site
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Shelby, North Carolina, 미국, 28152
- Novartis Investigative Site
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Winston-Salem, North Carolina, 미국, 27103
- Novartis Investigative Site
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Ohio
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Cincinnati, Ohio, 미국, 45246
- Novartis Investigative Site
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Columbus, Ohio, 미국, 43213
- Novartis Investigative Site
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Lyndhurst, Ohio, 미국, 44124
- Novartis Investigative Site
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Marion, Ohio, 미국, 43302
- Novartis Investigative Site
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Oklahoma
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Norman, Oklahoma, 미국, 73069
- Novartis Investigative Site
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Oregon
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Eugene, Oregon, 미국, 97404
- Novartis Investigative Site
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Oregon City, Oregon, 미국, 97045
- Novartis Investigative Site
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Portland, Oregon, 미국, 97239
- Novartis Investigative Site
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Tennessee
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Knoxville, Tennessee, 미국, 37920
- Novartis Investigative Site
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Texas
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Beaumont, Texas, 미국, 77702
- Novartis Investigative Site
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Houston, Texas, 미국, 77081
- Novartis Investigative Site
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Lake Jackson, Texas, 미국, 77566
- Novartis Investigative Site
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Pasadena, Texas, 미국, 77504
- Novartis Investigative Site
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Utah
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Centerville, Utah, 미국, 84104
- Novartis Investigative Site
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Virginia
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Arlington, Virginia, 미국, 22203
- Novartis Investigative Site
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Ettrick, Virginia, 미국, 23803
- Novartis Investigative Site
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Midlothian, Virginia, 미국, 23114
- Novartis Investigative Site
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Washington
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Port Orchard, Washington, 미국, 98366
- Novartis Investigative Site
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Madrid, 스페인, 28009
- Novartis Investigative Site
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Cataluña
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Barcelona, Cataluña, 스페인, 08905
- Novartis Investigative Site
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Centelles, Cataluña, 스페인, 08540
- Novartis Investigative Site
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Corbera de Llobregat, Cataluña, 스페인, 08757
- Novartis Investigative Site
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Hostalets de Balenya, Cataluña, 스페인, 08550
- Novartis Investigative Site
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Vic, Cataluña, 스페인, 08500
- Novartis Investigative Site
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Comunidad Valenciana
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Alzira, Comunidad Valenciana, 스페인, 46600
- Novartis Investigative Site
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Quart de Poblet, Comunidad Valenciana, 스페인, 46930
- Novartis Investigative Site
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Bratislava, 슬로바키아, 821 07
- Novartis Investigative Site
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Martin, 슬로바키아, 036 01
- Novartis Investigative Site
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Presov, 슬로바키아, 080 01
- Novartis Investigative Site
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Sala, 슬로바키아, 927 03
- Novartis Investigative Site
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Zvolen, 슬로바키아, 960 01
- Novartis Investigative Site
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Slovak Republic
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Kosice, Slovak Republic, 슬로바키아, 040 11
- Novartis Investigative Site
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Svidnik, Slovak Republic, 슬로바키아, 08901
- Novartis Investigative Site
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Slovak republic
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Banská Bystrica, Slovak republic, 슬로바키아, 97405
- Novartis Investigative Site
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Bratislava, Slovak republic, 슬로바키아, 83299
- Novartis Investigative Site
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Kosice, Slovak republic, 슬로바키아, 04001
- Novartis Investigative Site
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Nitra, Slovak republic, 슬로바키아, 95201
- Novartis Investigative Site
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Rimavska Sobota, Slovak republic, 슬로바키아, 97901
- Novartis Investigative Site
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Senec, Slovak republic, 슬로바키아, 90301
- Novartis Investigative Site
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Snina, Slovak republic, 슬로바키아, 09601
- Novartis Investigative Site
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Trnava, Slovak republic, 슬로바키아, 91701
- Novartis Investigative Site
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IS
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Pozzilli, IS, 이탈리아, 86077
- Novartis Investigative Site
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PV
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Pavia, PV, 이탈리아, 27100
- Novartis Investigative Site
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SS
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Sassari, SS, 이탈리아, 07100
- Novartis Investigative Site
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New Brunswick
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Moncton, New Brunswick, 캐나다, E1G 1A7
- Novartis Investigative Site
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, 캐나다, A1A 3R5
- Novartis Investigative Site
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Ontario
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Brampton, Ontario, 캐나다, L6T 0G1
- Novartis Investigative Site
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Toronto, Ontario, 캐나다, M9W 4L6
- Novartis Investigative Site
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Quebec
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Mirabel, Quebec, 캐나다, J7J 2K8
- Novartis Investigative Site
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Sainte-Foy, Quebec, 캐나다, G1W 4R4
- Novartis Investigative Site
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Carolina, 푸에르토 리코, 00983
- Novartis Investigative Site
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Cidra, 푸에르토 리코, 00739
- Novartis Investigative Site
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Manati, 푸에르토 리코, 00674
- Novartis Investigative Site
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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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공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Aliskiren: Fed
Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
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Aliskiren 300 mg once daily
다른 이름들:
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실험적: Aliskiren: Fasting
Aliskiren 300 mg once daily taken after after an overnight fast
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Aliskiren 300 mg once daily
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Systolic Blood Pressure (maSBP)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline (Visit 3) to End of Study (Week 8) in Mean 24 Hour Ambulatory Diastolic Blood Pressure (maDBP)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 8 weeks
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8 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2012년 4월 1일
기본 완료 (실제)
2012년 11월 1일
연구 완료 (실제)
2012년 11월 1일
연구 등록 날짜
최초 제출
2012년 4월 2일
QC 기준을 충족하는 최초 제출
2012년 4월 2일
처음 게시됨 (추정)
2012년 4월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 1월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 1월 15일
마지막으로 확인됨
2014년 1월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- CSPP100A2413
- 2011-005297-36 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .