Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Patients With Type 2 Diabetes and Incipient or Overt Nephropathy
A Randomized, Double-blind, Cross-over, 4-period, 4 Treatment, Within-subject Placebo-controlled Study to Assess the Optimal Renoprotective Dose of Aliskiren in Hypertensive Type 2 Diabetic Patients With Incipient or Overt Nephropathy
1 other identifier
interventional
26
1 country
1
Brief Summary
This study will assess the optimal renoprotective dose of Aliskiren in hypertensive type 2 diabetes patients with incipient or overt nephropathy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 21, 2007
CompletedFirst Posted
Study publicly available on registry
April 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedFebruary 4, 2011
February 1, 2011
2.5 years
April 21, 2007
February 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Investigate the antiproteinuric effect of increasing doses of Aliskiren compared to matching placebo.
End of study
Secondary Outcomes (3)
Assess the effect on Glomerular Filtration Rate (GFR) of multiple dose administration of Aliskiren.
End of study
Assess the effect on blood pressure of multiple dose administration of Aliskiren.
End of study
To investigate whether there is a change in biomarkers of inflammation and cardiovascular risk.
End of study
Study Arms (4)
1
EXPERIMENTALVarious sequences of 3 doses of Aliskiren plus placebo
2
EXPERIMENTALVarious sequences of 3 doses of Aliskiren plus placebo
3
EXPERIMENTALVarious sequences of 3 doses of Aliskiren plus placebo
4
EXPERIMENTALVarious sequences of 3 doses of Aliskiren plus placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male and/or female patients from 30-80 years of age.
- Type 2 diabetes (defined using World Health Organization criteria)
- Incipient or overt nephropathy (urinary albumin excretion 100 but ≤ 2000 mg/day).
- Glomerular filtration rate (GFR) 40ml per minute
- To be eligible for randomization, patients must fulfill the following criteria:
- Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to Visit 2 (Run-in period)
- Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at Visit 3 (Day -1, Period 1)
- Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening
- Oral body temperature within the range 35.0-37.5 °C
- Able to provide written informed consent prior to study participation.
- Able to communicate well with the investigator and comply with the requirements of the study.
- Patients must be willing and medically able to discontinue anti-hypertensive treatment or any other medication which is prohibited in the study protocol.
- Patients must be on stable hypoglycemic medications for at least 8 weeks prior to visit 1 (Screening visit).
You may not qualify if:
- Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- Severe Hypertension Grade 3 WHO classification Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
- Acetylsalicyclic acid (ASA) treatment \>1g/day or regular use of Non steroidal anti-inflammatory drugs (NSAIDs)
- Kidney disease not caused by diabetes or hypertension
- Serum potassium \< 3.5 or \> 5.1 mEq/L
- GFR \< 40 ml/min/1.73m2 as measured by the Modification of Diet in Renal Disease (MDRD) formula
- Serum albumin \< 2.0mg/dL
- History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit 1
- Transient ischemic cerebral attack during the 6 months prior to Visit 1
- Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV
- History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
- Second or third degree heart block without a pacemaker
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- Clinically significant valvular heart disease
- Type 1 diabetes mellitus
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (1)
Novartis
Gentofte Municipality, 2820, Denmark
Related Publications (1)
Persson F, Rossing P, Reinhard H, Juhl T, Stehouwer CD, Schalkwijk C, Danser AH, Boomsma F, Frandsen E, Parving HH. Optimal antiproteinuric dose of aliskiren in type 2 diabetes mellitus: a randomised crossover trial. Diabetologia. 2010 Aug;53(8):1576-80. doi: 10.1007/s00125-010-1789-6. Epub 2010 May 18.
PMID: 20480132DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Investigative site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 21, 2007
First Posted
April 24, 2007
Study Start
October 1, 2005
Primary Completion
April 1, 2008
Last Updated
February 4, 2011
Record last verified: 2011-02