Safety and Efficacy of Aliskiren on the Progression of Atherosclerosis in Coronary Artery Disease Patients (AQUARIUS)
This study is currently recruiting participants.
Verified December 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00853827
First received: February 26, 2009
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease (CAD) Coronary Atherosclerosis |
Drug: Placebo Drug: Aliskiren |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in the progression of coronary atherosclerosis (defined as change from baseline in percent atheroma volume) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in normalized total atheroma volume as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Proportion of patients that demonstrate evidence of atheroma regression (defined as any reduction in percent atheroma volume from baseline) as assessed by IVUS [ Time Frame: 104 weeks ] [ Designated as safety issue: No ]
- Overall safety and tolerability of aliskiren compared to placebo following treatment duration [ Time Frame: 104 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 592 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
Placebo
|
|
Experimental: 2
Aliskiren 300 mg
|
Drug: Aliskiren
300 mg
|
Eligibility| Ages Eligible for Study: | 35 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853827
Hide Study Locations
Contacts
| Contact: Novartis Pharmaceuticals | +1(862)778-8300 |
Hide Study LocationsLocations
| United States, Alabama | |
| Novartis Investigative Site | Withdrawn |
| Birmingham, Alabama, United States, 35209 | |
| Novartis Investigative Site | Terminated |
| Mobile, Alabama, United States, 36693 | |
| United States, Arizona | |
| Novartis Investigative Site | Withdrawn |
| *see Various Departments*, Arizona, United States | |
| Novartis Investigative Site | Active, not recruiting |
| Phoenix, Arizona, United States, 85054 | |
| Novartis Investigative Site | Active, not recruiting |
| Tucson, Arizona, United States, 85723-0001 | |
| Novartis Investigative Site | Active, not recruiting |
| Tucson, Arizona, United States, 85745 | |
| United States, California | |
| Novartis Investigative Site | Terminated |
| Los Angeles, California, United States, 90095 | |
| Novartis Investigative Site | Active, not recruiting |
| Los Angeles, California, United States, 90033 | |
| Novartis Investigative Site | Completed |
| San Diego, California, United States, 92161 | |
| Novartis Investigative Site | Withdrawn |
| Santa Rosa, California, United States, 95405 | |
| Novartis Investigative Site | Withdrawn |
| Stanford, California, United States, 94305 | |
| Novartis Investigative Site | Terminated |
| Stockton, California, United States, 95204 | |
| Novartis Investigative Site | Completed |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Novartis Investigative Site | Withdrawn |
| Aurora, Colorado, United States, 80045 | |
| Novartis Investigative Site | Completed |
| Boulder, Colorado, United States, 80304 | |
| Novartis Investigative Site | Withdrawn |
| Greeley, Colorado, United States, 80631 | |
| United States, Connecticut | |
| Novartis Investigative Site | Active, not recruiting |
| Farmington, Connecticut, United States, 06030-3100 | |
| United States, District of Columbia | |
| Novartis Investigative Site | Completed |
| Washington, District of Columbia, United States, 20010 | |
| Novartis Investigative Site | Terminated |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| Novartis Investigative Site | Terminated |
| Gainesville, Florida, United States, 32610 | |
| Novartis Investigative Site | Active, not recruiting |
| Hudson, Florida, United States, 34667 | |
| Novartis Investigative Site | Terminated |
| Miami, Florida, United States, 33137-3732 | |
| Novartis Investigative Site | Withdrawn |
| Pensacola, Florida, United States, 32501 | |
| Novartis Investigative Site | Completed |
| Port Charlotte, Florida, United States, 33952 | |
| Novartis Investigative Site | Completed |
| Safety Harbor, Florida, United States, 34695 | |
| United States, Georgia | |
| Novartis Investigative Site | Active, not recruiting |
| Decatur, Georgia, United States, 30033 | |
| United States, Indiana | |
| Novartis Investigative Site | Active, not recruiting |
| Elkhart, Indiana, United States, 46514 | |
| United States, Kentucky | |
| Novartis Investigative Site | Completed |
| Lexington, Kentucky, United States, 40536 | |
| Novartis Investigative Site | Terminated |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Novartis Investigative Site | Completed |
| Covington, Louisiana, United States, 70433 | |
| United States, Maryland | |
| Novartis Investigative Site | Terminated |
| Columbia, Maryland, United States, 21044 | |
| United States, Massachusetts | |
| Novartis Investigative Site | Completed |
| Boston, Massachusetts, United States | |
| United States, Michigan | |
| Novartis Investigative Site | Withdrawn |
| Ann Arbor, Michigan, United States, 48106 | |
| Novartis Investigative Site | Terminated |
| Flint, Michigan, United States, 48532 | |
| Novartis Investigative Site | Completed |
| Kalamazoo, Michigan, United States, 49048 | |
| Novartis Investigative Site | Completed |
| Midland, Michigan, United States, 48640 | |
| Novartis Investigative Site | Completed |
| Petoskey, Michigan, United States, 49770 | |
| Novartis Investigative Site | Terminated |
| Saginaw, Michigan, United States, 48601 | |
| United States, Minnesota | |
| Novartis Investigative Site | Withdrawn |
| Duluth, Minnesota, United States, 55805 | |
| Novartis Investigative Site | Terminated |
| Rochester, Minnesota, United States, 55905-0001 | |
| Novartis Investigative Site | Withdrawn |
| St. Cloud, Minnesota, United States, 56303 | |
| Novartis Investigative Site | Terminated |
| St. Paul, Minnesota, United States, 55102 | |
| United States, Missouri | |
| Novartis Investigative Site | Active, not recruiting |
| Columbia, Missouri, United States, 65212 | |
| United States, Nebraska | |
| Novartis Investigative Site | Withdrawn |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Jersey | |
| Novartis Investigative Site | Terminated |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New Mexico | |
| Novartis Investigative Site | Active, not recruiting |
| Albuquerque, New Mexico, United States, 87131-5271 | |
| United States, New York | |
| Novartis Investigative Site | Completed |
| Buffalo, New York, United States, 14215 | |
| Novartis Investigative Site | Terminated |
| New York, New York, United States, 10011 | |
| Novartis Investigative Site | Withdrawn |
| Rochester, New York, United States, 14642 | |
| Novartis Investigative Site | Withdrawn |
| Suffern, New York, United States, 10901 | |
| Novartis Investigative Site | Active, not recruiting |
| Syracuse, New York, United States, 13210-1640 | |
| Novartis Investigative Site | Completed |
| Williamsville, New York, United States, 14221 | |
| United States, North Carolina | |
| Novartis Investigative Site | Withdrawn |
| Greensboro, North Carolina, United States, 27401 | |
| Novartis Investigative Site | Completed |
| Raleigh, North Carolina, United States, 27610 | |
| United States, North Dakota | |
| Novartis Investigative Site | Completed |
| Fargo, North Dakota, United States, 58122 | |
| United States, Ohio | |
| Novartis Investigative Site | Withdrawn |
| Cleveland, Ohio, United States, 44195 | |
| Novartis Investigative Site | Terminated |
| Cleveland, Ohio, United States, 44109-1998 | |
| Novartis Investigative Site | Withdrawn |
| Columbus, Ohio, United States, 43214 | |
| Novartis Investigative Site | Withdrawn |
| Mansfield, Ohio, United States, 44902 | |
| Novartis Investigative Site | Withdrawn |
| Middleburg Heights, Ohio, United States, 44130 | |
| United States, Oklahoma | |
| Novartis Investigative Site | Active, not recruiting |
| Oklahoma City, Oklahoma, United States, 73109 | |
| Novartis Investigative Site | Active, not recruiting |
| Tulsa, Oklahoma, United States, 74104-4243 | |
| United States, Oregon | |
| Novartis Investigative Site | Terminated |
| Bend, Oregon, United States, 97701 | |
| Novartis Investigative Site | Active, not recruiting |
| Hillsboro, Oregon, United States, 97123 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | Terminated |
| Danville, Pennsylvania, United States, 17822-2001 | |
| Novartis Investigative Site | Withdrawn |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Novartis Investigative Site | Withdrawn |
| Lemoyne, Pennsylvania, United States, 17043 | |
| Novartis Investigative Site | Withdrawn |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| Novartis Investigative Site | Terminated |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Novartis Investigative Site | Completed |
| Johnson City, Tennessee, United States, 37604 | |
| Novartis Investigative Site | Withdrawn |
| Knoxville, Tennessee, United States, 37917 | |
| Novartis Investigative Site | Active, not recruiting |
| Memphis, Tennessee, United States, 38104 | |
| Novartis Investigative Site | Completed |
| Oak Ridge, Tennessee, United States, 37830 | |
| United States, Texas | |
| Novartis Investigative Site | Withdrawn |
| Amarillo, Texas, United States, 79106 | |
| Novartis Investigative Site | Completed |
| Dallas, Texas, United States, 75226 | |
| Novartis Investigative Site | Completed |
| Katy, Texas, United States, 77493 | |
| Novartis Investigative Site | Active, not recruiting |
| San Antonio, Texas, United States, 78229-3900 | |
| United States, Utah | |
| Novartis Investigative Site | Withdrawn |
| Murray, Utah, United States, 84157 | |
| Novartis Investigative Site | Withdrawn |
| Provo, Utah, United States, 84604 | |
| Argentina | |
| Novartis Investigative Site | Terminated |
| Buenos Aires, Capital Federal, Argentina, C1180AAX | |
| Novartis Investigative Site | Completed |
| Rosario, Santa Fe, Argentina, C2000DSR | |
| Novartis Investigative Site | Completed |
| Buenos Aires, Argentina, C1426ANZ | |
| Novartis Investigative Site | Active, not recruiting |
| Buenos Aires, Argentina, C1280AEB | |
| Novartis Investigative Site | Active, not recruiting |
| Buenos Aires, Argentina, C1428DCO | |
| Novartis Investigative Site | Completed |
| Buenos Aires, Argentina, C1039AAP | |
| Novartis Investigative Site | Completed |
| Buenos aires, Argentina, C1210AAP | |
| Novartis Investigative Site | Withdrawn |
| Buenos Aires, Argentina, C1425DTG | |
| Novartis Investigative Site | Withdrawn |
| Cordoba, Argentina, X5000FGG | |
| Novartis Investigative Site | Withdrawn |
| Cordoba, Argentina, X5000JHQ | |
| Novartis Investigative Site | Active, not recruiting |
| Corrientes, Argentina, 3400 | |
| Australia, New South Wales | |
| Novartis Investigative Site | Terminated |
| Camperdown, New South Wales, Australia, 2050 | |
| Novartis Investigative Site | Active, not recruiting |
| Liverpool, New South Wales, Australia, 2170 | |
| Novartis Investigative Site | Completed |
| New Lambton Heights, New South Wales, Australia, 2305 | |
| Australia, South Australia | |
| Novartis Investigative Site | Completed |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Novartis Investigative Site | Completed |
| Clayton, Victoria, Australia, 3168 | |
| Novartis Investigative Site | Withdrawn |
| Heidelberg, Victoria, Australia, 3084 | |
| Belgium | |
| Novartis Investigative Site | Completed |
| Aalst, Belgium, 9300 | |
| Novartis Investigative Site | Active, not recruiting |
| Anderlecht, Belgium, 1070 | |
| Novartis Investigative Site | Terminated |
| Brussel, Belgium, 1000 | |
| Novartis Investigative Site | Terminated |
| Bruxelles, Belgium, 1200 | |
| Novartis Investigative Site | Active, not recruiting |
| Charleroi, Belgium, 6000 | |
| Novartis Investigative Site | Completed |
| Genk, Belgium, 3600 | |
| Novartis Investigative Site | Withdrawn |
| Liege, Belgium, 4000 | |
| Novartis Investigative Site | Terminated |
| Ottignies, Belgium, 1340 | |
| Canada, Alberta | |
| Novartis Investigative Site | Completed |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Novartis Investigative Site | Active, not recruiting |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| Novartis Investigative Site | Withdrawn |
| Victoria, British Columbia, Canada, V8R4R2 | |
| Canada, Manitoba | |
| Novartis Investigative Site | Terminated |
| Winnipeg, Manitoba, Canada, R2H 3C3 | |
| Canada, Ontario | |
| Novartis Investigative Site | Completed |
| London, Ontario, Canada, N6A 5A5 | |
| Novartis Investigative Site | Terminated |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| Novartis Investigative Site | Active, not recruiting |
| Chicoutimi, Quebec, Canada, G7H 5H6 | |
| Novartis Investigative Site | Completed |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Novartis Investigative Site | Active, not recruiting |
| Montreal, Quebec, Canada, H1T 2M4 | |
| Canada | |
| Novartis Investigative Site | Completed |
| Quebec, Canada, G1V 4G5 | |
| France | |
| Novartis Investigative Site | Active, not recruiting |
| Creteil, France, 94010 | |
| Novartis Investigative Site | Active, not recruiting |
| Le Plessis Robinson, France, 92350 | |
| Novartis Investigative Site | Completed |
| Pessac Cedex, France, 33604 | |
| Novartis Investigative Site | Completed |
| Toulouse Cedex, France, 31059 | |
| Germany | |
| Novartis Investigative Site | Withdrawn |
| Bad Nauheim, Germany, 61231 | |
| Novartis Investigative Site | Withdrawn |
| Berlin, Germany, 13353 | |
| Novartis Investigative Site | Terminated |
| Coburg, Germany, 96450 | |
| Novartis Investigative Site | Active, not recruiting |
| Essen, Germany, 45122 | |
| Novartis Investigative Site | Completed |
| Frankfurt, Germany, 60316 | |
| Novartis Investigative Site | Completed |
| Hamburg, Germany, 20099 | |
| Novartis Investigative Site | Active, not recruiting |
| Hamburg, Germany, 20246 | |
| Novartis Investigative Site | Completed |
| Leipzig, Germany, 04289 | |
| Novartis Investigative Site | Terminated |
| Ludwigshafen, Germany, 67063 | |
| Novartis Investigative Site | Active, not recruiting |
| Muenchen, Germany, 81737 | |
| Novartis Investigative Site | Terminated |
| Neuss, Germany, 41464 | |
| Novartis Investigative Site | Withdrawn |
| Nürnberg, Germany, 90471 | |
| Novartis Investigative Site | Withdrawn |
| Stade, Germany, 21682 | |
| Hungary | |
| Novartis Investigative Site | Active, not recruiting |
| Pecs, Baranya, Hungary, 7621 | |
| Novartis Investigative Site | Active, not recruiting |
| Budapest, Hungary, 1134 | |
| Novartis Investigative Site | Active, not recruiting |
| Budapest, Hungary, 1122 | |
| Novartis Investigative Site | Active, not recruiting |
| Debrecen, Hungary, 4032 | |
| Novartis Investigative Site | Active, not recruiting |
| Szeged, Hungary, 6720 | |
| Italy | |
| Novartis Investigative Site | Terminated |
| Arezzo, AR, Italy, 52100 | |
| Novartis Investigative Site | Completed |
| Bergamo, BG, Italy, 24128 | |
| Novartis Investigative Site | Withdrawn |
| Genova, GE, Italy, 16128 | |
| Novartis Investigative Site | Withdrawn |
| Legnano, MI, Italy, 20025 | |
| Novartis Investigative Site | Completed |
| Milano, MI, Italy, 20132 | |
| Novartis Investigative Site | Withdrawn |
| Milano, MI, Italy, 20162 | |
| Novartis Investigative Site | Active, not recruiting |
| Rozzano, MI, Italy, 20089 | |
| Novartis Investigative Site | Completed |
| Sesto San Giovanni, MI, Italy, 20099 | |
| Novartis Investigative Site | Completed |
| Massa, MS, Italy, 54100 | |
| Novartis Investigative Site | Completed |
| Parma, PR, Italy, 43100 | |
| Novartis Investigative Site | Completed |
| Roma, RM, Italy, 00185 | |
| Novartis Investigative Site | Completed |
| Siena, SI, Italy, 53100 | |
| Novartis Investigative Site | Withdrawn |
| Udine, UD, Italy, 33100 | |
| Novartis Investigative Site | Active, not recruiting |
| Novara, Italy, 28100 | |
| Novartis Investigative Site | Withdrawn |
| Pisa, Italy, 56124 | |
| Poland | |
| Novartis Investigative Site | Recruiting |
| Bialystok, Poland, 15-276 | |
| Novartis Investigative Site | Withdrawn |
| Katowice, Poland, 40-637 | |
| Novartis Investigative Site | Withdrawn |
| Kedzierzyn Kozle, Poland, 47-200 | |
| Novartis Investigative Site | Recruiting |
| Kraków, Poland, 31-501 | |
| Novartis Investigative Site | Recruiting |
| Lódz, Poland, 90-549 | |
| Novartis Investigative Site | Recruiting |
| Warszawa, Poland, 04-628 | |
| Spain | |
| Novartis Investigative Site | Active, not recruiting |
| Málaga, Andalucía, Spain, 29010 | |
| Novartis Investigative Site | Active, not recruiting |
| Oviedo, Asturias, Spain, 33006 | |
| Novartis Investigative Site | Completed |
| Santander, Cantabria, Spain, 39008 | |
| Novartis Investigative Site | Completed |
| Barcelona, Cataluna, Spain, 08035 | |
| Novartis Investigative Site | Completed |
| Barcelona, Cataluna, Spain, 08003 | |
| Novartis Investigative Site | Active, not recruiting |
| Hospitalet de Llobregat, Cataluña, Spain, 08907 | |
| Novartis Investigative Site | Withdrawn |
| Alicante, Comunidad Valenciana, Spain, 03010 | |
| Novartis Investigative Site | Terminated |
| Santiago de Compostela, Galicia, Spain, 15706 | |
| Novartis Investigative Site | Active, not recruiting |
| Majadanonda, Madrid, Spain, 28220 | |
| Novartis Investigative Site | Completed |
| Galdakano, País Vasco, Spain, 48960 | |
| Novartis Investigative Site | Active, not recruiting |
| Vigo, Pontevedra, Spain, 36200 | |
| Novartis Investigative Site | Terminated |
| Barcelona, Spain, 08025 | |
| Novartis Investigative Site | Completed |
| Madrid, Spain, 28046 | |
| Novartis Investigative Site | Active, not recruiting |
| Madrid, Spain, 28040 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
The Cleveland Clinic
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Study Director: | Novartis | Novartis |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT00853827 History of Changes |
| Other Study ID Numbers: | CSPP100A2366, 2008-006447-40 |
| Study First Received: | February 26, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration Argentina: Ministry of Health Australia: Human Research Ethics Committee Belgium: Federal Agency for Medicinal Products and Health Products Canada: Health Canada France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: Research Ethics Medical Committee Italy: National Institute of Health Poland: Ministry of Health Spain: Spanish Agency of Medicines |
Keywords provided by Novartis:
|
CAD coronary artery disease coronary atherosclerosis coronary angiography IVUS |
intravascular ultrasound plasma renin activity renin angiotensin aldosterone system, direct renin inhibitors coronary atheroma |
Additional relevant MeSH terms:
|
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Coronary Disease Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on May 16, 2013