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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

Brief Summary:
Aliskiren (also called TekturnaTM) is a new drug for high blood pressure. Aliskiren works by blocking the actions of a substance called renin. Renin is a natural substance in the body that raises blood pressure. Renin is believed to contribute to the production of blood clots by increasing the amount of a substance known as Plasminogen Activator Inhibitor or PAI-1. This study will measure how aliskiren changes the amount of PAI-1 in the blood depending on the time of dosing. The purpose of this study is to find out if it is better to take aliskiren in the morning or at night.

Condition or disease Intervention/treatment Phase
High Blood Pressure Drug: Aliskiren 150 mg Drug: Placebo Drug: HCTZ Drug: Aliskiren 300 mg Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function
Study Start Date : June 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Aliskiren
U.S. FDA Resources

Arm Intervention/treatment
Experimental: HCTZ plus Aliskiren then HCTZ and Placebo

HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.

Then HCTZ 25 mg po plus Placebo

Drug: Aliskiren 150 mg
Aliskiren 150 mg daily for 2 weeks
Other Name: Tekturna
Drug: Placebo
Placebo tablet for Aliskerin
Drug: HCTZ
HCTZ 25mg every day for 18 weeks
Drug: Aliskiren 300 mg
Aliskiren 300 mg for 4 weeks
Experimental: HCTZ and Placebo, then HCTZ and Aliskiren

HCTZ 25 mg po plus Placebo.

Then HCTZ 25 mg plus Aliskiren 150mg for 2weeks. Aliskiren is increased to 300mg for 4 week if 150mg was tolerated.

Drug: Aliskiren 150 mg
Aliskiren 150 mg daily for 2 weeks
Other Name: Tekturna
Drug: Placebo
Placebo tablet for Aliskerin
Drug: HCTZ
HCTZ 25mg every day for 18 weeks
Drug: Aliskiren 300 mg
Aliskiren 300 mg for 4 weeks



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

Secondary Outcome Measures :
  1. Difference in Mean Plasma Aldosterone Levels [ Time Frame: baseline to 18 weeks ]
  2. Difference in Mean Changes in Plasma Renin Activity. [ Time Frame: baseline to 18 weeks ]
  3. Difference in Mean Plasma Peak Aldosterone Levels [ Time Frame: baseline to 18 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults 18-65 with hypertension

    • Hypertension is defined as a systolic blood pressure at screening of ≥ 140, a diastolic blood pressure of ≥ 90, or a preexisting diagnosis of hypertension taking antihypertensive medication. If the subject is on anti-hypertensive medication, they can be included in the study, independent of the screening blood pressure.

Exclusion Criteria:

  • Serum potassium > 5.0 mmol/L (at the visit directly preceding Randomization)
  • History of any cardiovascular event (stroke, TIA, MI, unstable angina, CABG, percutaneous coronary intervention, hospitalization due to HF) during the 3 months prior to Visit 1 or subsequent to enrollment.
  • Malignant Hypertension (at Randomization): any patient with SBP > 170 mmHg or DBP > 120 mmHg
  • Congestive heart failure NYHA class III and IV
  • Unstable serum creatinine
  • Second (II) or third (III) degree heart block without a pacemaker.
  • Concurrent potentially life threatening arrhythmia or other uncontrolled arrhythmia.
  • Clinically significant valvular heart disease.
  • Known renal artery stenosis.
  • Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of the study drugs including, but not limited to, any of the following:
  • History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection (patients with previous bariatric surgery > 6 months prior to Visit 1 are allowed to participate).
  • Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase.
  • Evidence of hepatic disease as determined by any one of the following: SGPT value exceeding 3 x Upper Limit of Normal (ULN) at Visit 1, a history of hepatic encephalopathy, a history of cirrhosis, esophageal varices, or a history of portocaval shunt.
  • History of malignancy other than basal cell skin cancer within the past five years.
  • Any concurrent life threatening condition with a life expectancy less than 2 years.
  • History or evidence of drug or alcohol abuse within the last 12 months.
  • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
  • History of hypersensitivity to any of the study drugs or to medications belonging to the same therapeutic class as the study drugs as well as known or suspected contraindications to the study drugs.
  • History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
  • Any condition that in the opinion of the investigator would jeopardize the evaluation of efficacy or safety.
  • Persons directly involved in the execution of this protocol.
  • Pregnant or nursing (lactating) women
  • Transmeridian travel in the past 6 months
  • Screening physical and lab findings consistent with the AHA/ADA metabolic syndrome criteria (3 of the following: BP ≥ 130/85 or on antihypertensive medications, waist size > 40" (m) > 35" (f), Fasting Glucose ≥ 100 mg/dl, Triglycerides ≥ 150 mg/dl, HDL <40 mg/dl (m) <50 mg/dl (f))
  • Smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115853


Locations
United States, Tennessee
VUMC
Nashville, Tennessee, United States
Sponsors and Collaborators
Vanderbilt University Medical Center

Responsible Party: James Muldowney, Assistant Director, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03115853     History of Changes
Other Study ID Numbers: 090738
First Posted: April 14, 2017    Key Record Dates
Results First Posted: August 25, 2017
Last Update Posted: August 25, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases