To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy
NCT ID: NCT01302899
Last Updated: 2013-01-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2011-01-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram
Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.
Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.
Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Aliskiren
Aliskiren 150 mg (Tablet)
Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril
Ramipril 10mg (Tablet)
Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram
Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.
Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.
Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.
Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Aliskiren
Aliskiren 150 mg (Tablet)
Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril
Ramipril 10mg (Tablet)
Interventions
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Aliskiren
Aliskiren 150 mg (Tablet)
Placebo to Aliskiren
Aliskiren 150 mg Matching Placebo (Tablet)
Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule)
Placebo to Hydrochlorothiazide (HCTZ)
HCTZ 25mg (Capsule) Matching Placebo
Ramipril
Ramipril 10mg (Tablet)
Eligibility Criteria
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Inclusion Criteria
* Patients with chronic kidney disease of non-diabetic origin
* Glomerular filtration rate \>30 ml/min/1.73m2
* Patients with a history of hypertension and msSBP (mean systolic blood pressure) of \<160 mm Hg and msDBP (mean diastolic blood pressure) \<105 mm Hg at screening and baseline.
* Subjects must have a body mass index (BMI) within the range of 18 and 35 kg/m2
Exclusion Criteria
* Severe hypertension (msDBP ≥110 mmHg and msSBP ≥180 mmHg)
* Pregnant or nursing (lactating) women,
* A medical history of unstable coronary artery disease, myocardial infarction, coronary bypass surgery or cerebrovascular accident within the last six (6) months
* Diabetes mellitus, Heart failure
* High rate of renal function loss
* History of severe hypersensitivity or contraindications to any of the medications or drugs belonging to the similar therapeutic class as the study drugs and the excipients.
* History of liver disease, positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
* History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Groningen, , Netherlands
Novartis Investigative Site
Leeuwarden, , Netherlands
Countries
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Other Identifiers
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2009-012196-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CSPP100A2260
Identifier Type: -
Identifier Source: org_study_id
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