Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)
Public ClinicalTrials.gov record NCT00549757. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Determine Whether, in Patients With Type 2 Diabetes at High Risk for Cardiovascular and Renal Events, Aliskiren, on Top of Conventional Treatment, Reduces Cardiovascular and Renal Morbidity and Mortality
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney. AMENDMENT 4 RATIONALE (MARCH 2012) : Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.
Study identification
- NCT ID
- NCT00549757
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 8,606 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 35 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2007 (Type not available)
- Primary completion
- Feb 2013 (Actual)
- Completion
- Feb 2013 (Actual)
- Last update posted
- Apr 21, 2014
2007 – 2013
United States locations
- U.S. sites
- 118
- U.S. states
- 36
- U.S. cities
- 102
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | — |
| Novartis Investigative Site | Birmingham | Alabama | 35235 | — |
| Novartis Investigative Site | Huntsville | Alabama | 35801 | — |
| Novartis Investigative Site | Mobile | Alabama | 36608 | — |
| Novartis Investigative Site | Mobile | Alabama | 36617 | — |
| Novartis Investigative Site | Montgomery | Alabama | 36106 | — |
| Novartis Investigative Site | Muscle Shoals | Alabama | 35662 | — |
| Novartis Investigative Site | Peoria | Arizona | 85381 | — |
| Novartis Investigative Site | Phoenix | Arizona | 85032 | — |
| Novartis Investigative Site | Tucson | Arizona | 85712 | — |
| Novartis Investigative Site | Tucson | Arizona | 85741 | — |
| Novartis Investigative Site | Fayetteville | Arkansas | 72703 | — |
| Novartis Investigative Site | Burlingame | California | 94010 | — |
| Novartis Investigative Site | Fullerton | California | 92835 | — |
| Novartis Investigative Site | Huntington Beach | California | 92648 | — |
| Novartis Investigative Site | Oakland | California | 94609 | — |
| Novartis Investigative Site | Pasadena | California | 91101 | — |
| Novartis Investigative Site | Riverside | California | 92501 | — |
| Novartis Investigative Site | Spring Valley | California | 91978-1522 | — |
| Novartis Investigative Site | Torrance | California | 90502 | — |
| Novartis Investigative Site | Walnut Creek | California | 94598 | — |
| Novartis Investigative Site | Denver | Colorado | 80209 | — |
| Novartis Investigative Site | Bridgeport | Connecticut | 06610 | — |
| Novartis Investigative Site | Aventura | Florida | 33180 | — |
| Novartis Investigative Site | Boca Raton | Florida | 33433 | — |
| Novartis Investigative Site | Fort Lauderdale | Florida | 33311 | — |
| Novartis Investigative Site | Hollywood | Florida | 33021 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32204 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32205 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32209 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | — |
| Novartis Investigative Site | Lauderdale Lakes | Florida | 33313 | — |
| Novartis Investigative Site | Pensacola | Florida | 32504 | — |
| Novartis Investigative Site | Plantation | Florida | 33324 | — |
| Novartis Investigative Site | West Palm Beach | Florida | 33401 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30309 | — |
| Novartis Investigative Site | Augusta | Georgia | 30904 | — |
| Novartis Investigative Site | Augusta | Georgia | 30909 | — |
| Novartis Investigative Site | Cumming | Georgia | 30041 | — |
| Novartis Investigative Site | Honolulu | Hawaii | 96813 | — |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | — |
| Novartis Investigative Site | Champaign | Illinois | 61820 | — |
| Novartis Investigative Site | Lake Zurich | Illinois | 60047 | — |
| Novartis Investigative Site | Peoria | Illinois | 61615 | — |
| Novartis Investigative Site | Topeka | Kansas | 66606 | — |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | — |
| Novartis Investigative Site | Metairie | Louisiana | 70006 | — |
| Novartis Investigative Site | Slidell | Louisiana | 70458 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21204 | — |
| Novartis Investigative Site | Burlington | Massachusetts | 01803 | — |
| Novartis Investigative Site | Haverhill | Massachusetts | 01830 | — |
| Novartis Investigative Site | Jamaica Plain | Massachusetts | 02130 | — |
| Novartis Investigative Site | Natick | Massachusetts | 01760 | — |
| Novartis Investigative Site | North Dartmouth | Massachusetts | 02747 | — |
| Novartis Investigative Site | Waltham | Massachusetts | 02154 | — |
| Novartis Investigative Site | Worcester | Massachusetts | 01609 | — |
| Novartis Investigative Site | Ann Arbor | Michigan | 48109 | — |
| Novartis Investigative Site | Detroit | Michigan | 48202 | — |
| Novartis Investigative Site | Detroit | Michigan | 48236 | — |
| Novartis Investigative Site | Kalamazoo | Michigan | 49048 | — |
| Novartis Investigative Site | Livonia | Michigan | 48154 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55404 | — |
| Novartis Investigative Site | Minneapolis | Minnesota | 55455 | — |
| Novartis Investigative Site | Saint Louis Park | Minnesota | 55416 | — |
| Novartis Investigative Site | Belzoni | Mississippi | 39038 | — |
| Novartis Investigative Site | Gulfport | Mississippi | 39501 | — |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | — |
| Novartis Investigative Site | Springfield | Missouri | 65807 | — |
| Novartis Investigative Site | St Louis | Missouri | 63110-1093 | — |
| Novartis Investigative Site | St Louis | Missouri | 63141 | — |
| Novartis Investigative Site | Fremont | Nebraska | 68025 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68131 | — |
| Novartis Investigative Site | Dover | New Hampshire | 03820-2403 | — |
| Novartis Investigative Site | Princeton Junction | New Jersey | 08550 | — |
| Novartis Investigative Site | Albuquerque | New Mexico | 87106 | — |
| Novartis Investigative Site | Albany | New York | 12206 | — |
| Novartis Investigative Site | Rochester | New York | 14607 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45236 | — |
| Novartis Investigative Site | Cleveland | Ohio | 44115 | — |
| Novartis Investigative Site | Lyndhurst | Ohio | 44124 | — |
| Novartis Investigative Site | Norman | Oklahoma | 73069 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73112 | — |
| Novartis Investigative Site | Tulsa | Oklahoma | 74133 | — |
| Novartis Investigative Site | Allentown | Pennsylvania | 18103 | — |
| Novartis Investigative Site | Lancaster | Pennsylvania | 17604 | — |
| Novartis Investigative Site | Lansdale | Pennsylvania | 19446 | — |
| Novartis Investigative Site | Melrose Park | Pennsylvania | 19027 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19138 | — |
| Novartis Investigative Site | Wyomissing | Pennsylvania | 19610 | — |
| Novartis Investigative Site | Warwick | Rhode Island | 02886 | — |
| Novartis Investigative Site | Aiken | South Carolina | 29801 | — |
| Novartis Investigative Site | Charleston | South Carolina | 29425 | — |
| Novartis Investigative Site | Columbia | South Carolina | 29201 | — |
| Novartis Investigative Site | Greenville | South Carolina | 29605 | — |
| Novartis Investigative Site | Orangeburg | South Carolina | 29115 | — |
| Novartis Investigative Site | Collierville | Tennessee | 38017 | — |
| Novartis Investigative Site | Amarillo | Texas | 79106 | — |
| Novartis Investigative Site | Austin | Texas | 78731 | — |
| Novartis Investigative Site | Dallas | Texas | 75226 | — |
| Novartis Investigative Site | Dallas | Texas | 75231 | — |
| Novartis Investigative Site | Dallas | Texas | 75235 | — |
| Novartis Investigative Site | Dallas | Texas | 75390 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | Irving | Texas | 75039 | — |
| Novartis Investigative Site | McAllen | Texas | 78501 | — |
| Novartis Investigative Site | North Richland Hills | Texas | 76180 | — |
| Novartis Investigative Site | Plano | Texas | 75024 | — |
| Novartis Investigative Site | San Antonio | Texas | 78207 | — |
| Novartis Investigative Site | San Antonio | Texas | 78218 | — |
| Novartis Investigative Site | San Antonio | Texas | 78229-4801 | — |
| Novartis Investigative Site | Temple | Texas | 76508-0002 | — |
| Novartis Investigative Site | Bennington | Vermont | 05201 | — |
| Novartis Investigative Site | Burlington | Vermont | 05401 | — |
| Novartis Investigative Site | Alexandria | Virginia | 22304-2315 | — |
| Novartis Investigative Site | Burke | Virginia | 22015 | — |
| Novartis Investigative Site | Renton | Washington | 98055 | — |
| Novartis Investigative Site | Charleston | West Virginia | 25301 | — |
| Novartis Investigative Site | Appleton | Wisconsin | 54911 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 658 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00549757, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2014 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00549757 live on ClinicalTrials.gov.