Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients

Coronary Artery Disease (CAD) Clinical Trial

— AQUARIUS  

Official title:

A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853827
• Other study ID #: CSPP100A2366
• Secondary ID: 2008-006447-40
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2009
• Last updated: May 20, 2014
• Start date: March 2009
• Est. completion date: January 2013

Study information

• Verified date: May 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Ministry of HealthAustralia: Human Research Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: Research Ethics Medical CommitteeItaly: National Institute of HealthPoland: Ministry of HealthSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP = 125 and = 139mmHg and a msDBP < 90mmHg.

• Patients with or without current treatment for hypertension

• Angiographic evidence of coronary artery disease

• At least 2 qualifying Cardiovascular risk factors at Visit 1

Exclusion Criteria:

• Baseline IVUS determined unacceptable

• Patients requiring treatment with disallowed study medications

• Patients with clinically significant heart disease

• Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%

• Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:

• Angiotensin converting enzyme inhibitors

• Angiotensin receptor blockers

• aldosterone receptor blockers or a direct renin inhibitor.

• Other conditions may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Artery Disease (CAD)
• Coronary Atherosclerosis
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Placebo
Placebo
• Aliskiren
300 mg

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires	Capital Federal
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Corrientes
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Camperdown	New South Wales
Australia	Novartis Investigative Site	Clayton	Victoria
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	New Lambton Heights	New South Wales
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Anderlecht
Belgium	Novartis Investigative Site	Brussel
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Charleroi
Belgium	Novartis Investigative Site	Genk
Belgium	Novartis Investigative Site	Ottignies
Canada	Novartis Investigative Site	Chicoutimi	Quebec
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Winnipeg	Manitoba
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Le Plessis Robinson
France	Novartis Investigative Site	Pessac Cedex
France	Novartis Investigative Site	Toulouse Cedex
Germany	Novartis Investigative Site	Coburg
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Ludwigshafen
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Neuss
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Pecs	Baranya
Hungary	Novartis Investigative Site	Szeged
Italy	Novartis Investigative Site	Arezzo	AR
Italy	Novartis Investigative Site	Bergamo	BG
Italy	Novartis Investigative Site	Massa	MS
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Novara
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Sesto San Giovanni	MI
Italy	Novartis Investigative Site	Siena	SI
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Kraków
Poland	Novartis Investigative Site	Lódz
Poland	Novartis Investigative Site	Warszawa
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Galdakano	Pais Vasco
Spain	Novartis Investigative Site	Hospitalet de Llobregat	Cataluña
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadanonda	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Oviedo	Asturias
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Santiago de Compostela	Galicia
Spain	Novartis Investigative Site	Vigo	Galicia
United States	Novartis Investigative Site	Albuquerque	New Mexico
United States	Novartis Investigative Site	Bend	Oregon
United States	Novartis Investigative Site	Boston	Massachusetts
United States	Novartis Investigative Site	Boulder	Colorado
United States	Novartis Investigative Site	Buffalo	New York
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Columbia	Missouri
United States	Novartis Investigative Site	Columbia	Maryland
United States	Novartis Investigative Site	Covington	Louisiana
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Danville	Pennsylvania
United States	Novartis Investigative Site	Decatur	Georgia
United States	Novartis Investigative Site	Elkhart	Indiana
United States	Novartis Investigative Site	Fargo	North Dakota
United States	Novartis Investigative Site	Farmington	Connecticut
United States	Novartis Investigative Site	Flint	Michigan
United States	Novartis Investigative Site	Gainesville	Florida
United States	Novartis Investigative Site	Hillsboro	Oregon
United States	Novartis Investigative Site	Hudson	Florida
United States	Novartis Investigative Site	Johnson City	Tennessee
United States	Novartis Investigative Site	Kalamazoo	Michigan
United States	Novartis Investigative Site	Katy	Texas
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Los Angeles	California
United States	Novartis Investigative Site	Louisville	Kentucky
United States	Novartis Investigative Site	Memphis	Tennessee
United States	Novartis Investigative Site	Miami	Florida
United States	Novartis Investigative Site	Midland	Michigan
United States	Novartis Investigative Site	Mobile	Alabama
United States	Novartis Investigative Site	New York	New York
United States	Novartis Investigative Site	Oak Ridge	Tennessee
United States	Novartis Investigative Site	Oklahoma City	Oklahoma
United States	Novartis Investigative Site	Petoskey	Michigan
United States	Novartis Investigative Site	Phoenix	Arizona
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Port Charlotte	Florida
United States	Novartis Investigative Site	Raleigh	North Carolina
United States	Novartis Investigative Site	Ridgewood	New Jersey
United States	Novartis Investigative Site	Rochester	Minnesota
United States	Novartis Investigative Site	Safety Harbor	Florida
United States	Novartis Investigative Site	Saginaw	Michigan
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	St. Paul	Minnesota
United States	Novartis Investigative Site	Stockton	California
United States	Novartis Investigative Site	Syracuse	New York
United States	Novartis Investigative Site	Torrance	California
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	Tulsa	Oklahoma
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	Washington	District of Columbia
United States	Novartis Investigative Site	Williamsville	New York

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals	The Cleveland Clinic

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Canada,  France,  Germany,  Hungary,  Italy,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment	Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases	Baseline, 104 weeks	No
Secondary	Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS	Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases	Baseline, 104 weeks	No
Secondary	Patients That Demonstrated Evidence of Atheroma Regression	Atheroma regression is defined as change from baseline to endpoint in PAV <0 .	Baseline to endpoint (104 weeks)	No
Secondary	Number of Patients With Adverse Events, Serious Adverse Events, and Death	overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.	104 weeks	Yes