The Effects of Renin Inhibition on Fibrinolytic Balance and Endothelial Function

Completed · Phase 4 · Has a placebo group

Conditions studied: High Blood Pressure

In brief

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.

Key facts

Study ID

NCT03115853

Run by

Vanderbilt University Medical Center

People needed

31

Starts

2009-06-01

Expected to finish

2012-01-01

Last updated by the study team

2017-08-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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))

Where it is running

• VUMC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.