Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133692
Status:
COMPLETED
Last Update Posted:
2011-09-20
First Post:
2005-08-22
Brief Title:
INVEST INternational VErapamil SR Trandolapril STudy
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
INternational VErapamil SR Trandolapril STudy
Status:
COMPLETED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Because blood pressure affects the heart blood vessels kidneys and the entire body it is important to keep it as normal as possible There are several different ways to control blood pressure and to prevent or limit the development of heart disease due to high blood pressure The purpose of this study is to compare two treatments to see how well they work and the difference in their side effects One treatment includes the use of a calcium antagonist drug Isoptin sustained release SR or Verapamil SR The other treatment excludes the calcium antagonist and may include a non-calcium antagonist drug called a beta blocker Tenormin or Atenolol Both treatments may also include medication called angiotensin converting enzyme ACE inhibitors and water pills None of the drugs in this study are experimental they are all approved by the Food and Drug Administration FDA
Detailed Description:
INVEST is an investigator initiated international prospective randomized study comparing two pharmacotherapy strategies to control hypertension in ambulatory patients with coronary artery disease CAD One strategy the calcium antagonist care strategy centers on a calcium antagonist verapamil SR followed by addition of an ACE inhibitor trandolapril and then diuretic hydrochlorothiazide as needed to achieve target blood pressures BP The other strategy the non-calcium antagonist care strategy uses a beta-blocker atenolol followed by addition of low-dose diuretic and then an ACE inhibitor trandolapril as needed to reach target BP In either strategy additional drugs can be added provided the calcium antagonist is retained in the calcium antagonist care strategy and calcium antagonists are omitted in the non-calcium antagonist care strategy
The study is organized into 15 international regions with about 1500 study investigators randomizing approximately 22000 patients who will be treated for at least two years The primary response variable is the occurrence of adverse outcome defined as any of the following events all cause mortality nonfatal MI or nonfatal stroke A number of secondary response variables including newly diagnosed diabetes will also be evaluated
The primary objective of this trial is to examine the hypothesis that the risk for adverse outcomes all cause mortality nonfatal MI or nonfatal stroke in hypertensive patients with CAD is at least equivalent during treatment of hypertension with a calcium antagonist strategy when compared with a non-calcium antagonist strategy
Unique features of INVEST are in addition to its size and international scope its design to mimic standard clinical practice and its all electronic online data entry drug distribution system study management system and electronic physician compensation This system will permit the entire trial to be conducted via the Internet This design is believed to be a forerunner of clinical trials research for the future
The study is organized into 15 international regions with about 1500 study investigators randomizing approximately 22000 patients who will be treated for at least two years The primary response variable is the occurrence of adverse outcome defined as any of the following events all cause mortality nonfatal MI or nonfatal stroke A number of secondary response variables including newly diagnosed diabetes will also be evaluated
The primary objective of this trial is to examine the hypothesis that the risk for adverse outcomes all cause mortality nonfatal MI or nonfatal stroke in hypertensive patients with CAD is at least equivalent during treatment of hypertension with a calcium antagonist strategy when compared with a non-calcium antagonist strategy
Unique features of INVEST are in addition to its size and international scope its design to mimic standard clinical practice and its all electronic online data entry drug distribution system study management system and electronic physician compensation This system will permit the entire trial to be conducted via the Internet This design is believed to be a forerunner of clinical trials research for the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None