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A Study to Investigate the Pharmacodynamic and Pharmacokinetic Interaction Between Aliskiren and Furosemide in Patients With Heart Failure

NCT ID: NCT01125514

Last Updated: 2012-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-08-31

Brief Summary

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This study assessed the interaction between single and multiple doses of aliskiren (150 mg and 300 mg) and furosemide (60 mg) in patients with heart failure.

Detailed Description

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Conditions

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Heart Failure

Keywords

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Heart failure, aliskiren, furosemide, diuretic efficacy, interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Furosemide 60 mg

Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.

Group Type EXPERIMENTAL

Furosemide 60 mg

Intervention Type DRUG

Furosemide 60 mg commercially-available tablets

Placebo for Aliskiren

Intervention Type DRUG

Matching placebo for aliskiren 150 mg and 300 mg

Furosemide 60 mg + Aliskiren 150 mg

Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.

Group Type EXPERIMENTAL

Aliskiren 150 mg

Intervention Type DRUG

Aliskiren 150 mg tablet

Furosemide 60 mg

Intervention Type DRUG

Furosemide 60 mg commercially-available tablets

Placebo for Aliskiren

Intervention Type DRUG

Matching placebo for aliskiren 150 mg and 300 mg

Furosemide 60 mg + Aliskiren 300 mg

Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.

Group Type EXPERIMENTAL

Furosemide 60 mg

Intervention Type DRUG

Furosemide 60 mg commercially-available tablets

Placebo for Aliskiren

Intervention Type DRUG

Matching placebo for aliskiren 150 mg and 300 mg

Aliskiren 300 mg

Intervention Type DRUG

Aliskiren 300 mg tablet

Interventions

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Aliskiren 150 mg

Aliskiren 150 mg tablet

Intervention Type DRUG

Furosemide 60 mg

Furosemide 60 mg commercially-available tablets

Intervention Type DRUG

Placebo for Aliskiren

Matching placebo for aliskiren 150 mg and 300 mg

Intervention Type DRUG

Aliskiren 300 mg

Aliskiren 300 mg tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Systolic or diastolic heart failure, diagnosed with either NYHA functional class II to III at least 3 months prior to screening and on stable medication for at least 12 weeks.
* Patients must have met either of the criteria at screening:
* Documented left ventricular ejection fraction (LVEF) greater than 20% but lower than 40% OR
* Patients with a documented LVEF greater than 40% and with a history of NT-pro-BNP\> 400pg/mL (or BNP \> 100pg/mL) within 12 months of screening.

Exclusion Criteria

* Treatment with Angiotensin Receptor Blockers (ARBs), aldosterone receptor antagonists and diuretics (other than furosemide) within 3 weeks of first dose and during the study. Beta blockers were permitted provided the dose was stable for at least 3 weeks before the first dose and remains so throughout the study.
* Hypertrophic cardiomyopathy (HCMP).
* If a subject is currently treated with furosemide, the dose must be stable for at least 3 weeks before the first dose and the dose must not exceed 60 mg daily
* Stable heart failure requiring treatment with both an ACE inhibitor and an ARB or Current acute decompensated heart failure.
* Mean sitting systolic blood pressure ≥160 mmHg and/or mean sitting diastolic blood pressure ≥ 100mmHg and/or secondary forms of hypertension.
* Persistent sitting systolic blood pressure \<90 mmHg.
* History of angioedema.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Vilnius, , Lithuania

Site Status

Countries

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Germany Lithuania

Other Identifiers

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CSPP100A2255

Identifier Type: -

Identifier Source: org_study_id