Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy of Coreg CR and Lisinopril on Markers for Cardiovascular Functional and Structural Disease (DETECT)

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00553969
First received: November 5, 2007
Last updated: December 9, 2014
Last verified: December 2014
Results First Received: December 16, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Pre-hypertension
Interventions: Drug: carvedilol phosphate
Drug: lisinopril
Drug: carvedilol phosphate and lisinopril
Drug: placebo and placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1 Coreg CR + Lisinopril

Coreg CR + lisinopril

carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

2 Coreg CR + Placebo

Coreg CR + placebo

carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months

3 Lisinopril + Placebo

lisinopril + placebo

lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

4 Placebo + Placebo No text entered.

Participant Flow:   Overall Study
    1 Coreg CR + Lisinopril     2 Coreg CR + Placebo     3 Lisinopril + Placebo     4 Placebo + Placebo  
STARTED     31     24     22     24  
COMPLETED     23     24     21     23  
NOT COMPLETED     8     0     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
1 Coreg CR + Lisinopril

Coreg CR + lisinopril

carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

2 Coreg CR + Placebo

Coreg CR + placebo

carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months

3 Lisinopril + Placebo

lisinopril + placebo

lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months

4 Placebo + Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    1 Coreg CR + Lisinopril     2 Coreg CR + Placebo     3 Lisinopril + Placebo     4 Placebo + Placebo     Total  
Number of Participants  
[units: participants]
  23     24     21     23     91  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     23     24     21     23     91  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  52  ± 13     53  ± 10     53  ± 10     51  ± 13     52.25  ± 11.5  
Gender  
[units: participants]
         
Female     6     7     5     8     26  
Male     17     17     16     15     65  
Region of Enrollment  
[units: participants]
         
United States     23     24     21     23     91  



  Outcome Measures

1.  Primary:   Change in Disease Score (DS) Among the Treatment Groups   [ Time Frame: Baseline and nine months ]

2.  Primary:   The Overall Rasmussen Disease Score (RDS) Change From Baseline to 9 Months Will be the Primary End-point.   [ Time Frame: 9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Quantitative Change in Each of the RDS Components From Baseline to 9 Months Will Serve as a Secondary End-point. The 3-month Data Will Provide Early Evidence for Drug Efficacy and Will be Analyzed Similarly as a Secondary End-point.   [ Time Frame: 3-9 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jay N. Cohn, M.D.
Organization: University of Minnesota Medical School
phone: 612.625.5646
e-mail: cohnx001@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00553969     History of Changes
Other Study ID Numbers: 0709M15829
Study First Received: November 5, 2007
Results First Received: December 16, 2013
Last Updated: December 9, 2014
Health Authority: United States: Institutional Review Board