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The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03115853
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Condition: High Blood Pressure
Interventions: Drug: Aliskiren 150 mg
Drug: Placebo
Drug: HCTZ
Drug: Aliskiren 300 mg

  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
The data for this study was lost. The total number of participants enrolled/completed was pulled from IRB records. Participant age was between 18-65 per protocol. All participants were enrolled in the United States. No other data is available.

Reporting Groups
All Participants all participants enrolled in the study

Participant Flow:   Overall Study
    All Participants

  Baseline Characteristics

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
All Participants No text entered.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
Participants Analyzed 
[Units: Participants]
<=18 years      0   0.0% 
Between 18 and 65 years      31 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
[1] Data lost
Region of Enrollment 
[Units: Participants]
United States   
Participants Analyzed 
[Units: Participants]
United States   31 

  Outcome Measures

1.  Primary:   Difference in Peak Plasma PAI-1 Level   [ Time Frame: baseline to 18 weeks ]

2.  Primary:   Difference in Mean Plasma PAI-1 Level   [ Time Frame: baseline to 18 weeks ]

3.  Secondary:   Difference in Mean Plasma Aldosterone Levels   [ Time Frame: baseline to 18 weeks ]

4.  Secondary:   Difference in Mean Changes in Plasma Renin Activity.   [ Time Frame: baseline to 18 weeks ]

5.  Secondary:   Difference in Mean Plasma Peak Aldosterone Levels   [ Time Frame: baseline to 18 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: James Muldowney, MD
Organization: Vanderbilt University Medical Center
phone: 615-936-1720
e-mail: james.muldowney@vanderbilt.edu

Responsible Party: James Muldowney, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03115853     History of Changes
Other Study ID Numbers: 090738
First Submitted: March 16, 2017
First Posted: April 14, 2017
Results First Submitted: July 25, 2017
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017