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The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function

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ClinicalTrials.gov Identifier: NCT03115853
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : August 25, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
James Muldowney, Vanderbilt University Medical Center

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
Enrollment 31
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title All Participants
Hide Arm/Group Description all participants enrolled in the study
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
Female
Male
[1]
Measure Analysis Population Description: Data lost
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
1.Primary Outcome
Title Difference in Peak Plasma PAI-1 Level
Hide Description [Not Specified]
Time Frame baseline to 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
data was lost and results are unknown
Arm/Group Title HCTZ Plus Aliskiren 150mg HCTZ Plus Aliskiren 300mg HCTZ and Placebo
Hide Arm/Group Description:
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg po plus Placebo.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Primary Outcome
Title Difference in Mean Plasma PAI-1 Level
Hide Description [Not Specified]
Time Frame baseline to 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
data was lost and results are unknown
Arm/Group Title HCTZ Plus Aliskiren 150mg HCTZ Plus Aliskiren 300mg HCTZ and Placebo
Hide Arm/Group Description:
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg po plus Placebo.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Difference in Mean Plasma Aldosterone Levels
Hide Description [Not Specified]
Time Frame baseline to 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HCTZ Plus Aliskiren 150mg HCTZ Plus Aliskiren 300mg HCTZ and Placebo
Hide Arm/Group Description:
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg po plus Placebo.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Difference in Mean Changes in Plasma Renin Activity.
Hide Description [Not Specified]
Time Frame baseline to 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HCTZ Plus Aliskiren 150mg HCTZ Plus Aliskiren 300mg HCTZ and Placebo
Hide Arm/Group Description:
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg po plus Placebo.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Difference in Mean Plasma Peak Aldosterone Levels
Hide Description [Not Specified]
Time Frame baseline to 18 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
data was lost and results are unknown
Arm/Group Title HCTZ Plus Aliskiren 150mg HCTZ Plus Aliskiren 300mg HCTZ and Placebo
Hide Arm/Group Description:
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.
HCTZ 25 mg po plus Placebo.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description data was lost; unable to provide information on adverse events
 
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
All Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Participants
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Participants
Affected / at Risk (%)
Total   0/0 
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
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