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โ† Trials
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A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension

RecruitingPhase 2Ages 18 Years - 75 YearsAllRetension Pharmaceuticals. Inc.
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male or female patients age 18 to 75 years, inclusive, at the Screening Visit. * Uncontrolled HTN despite being on a stable regimen of 2-5 antihypertensive medications. * Mean BP of โ‰ฅ135/80 mm Hg. * Body mass index of 18 to 35 kg/m2. Exclusion Criteria: * Mean seated SBP \>175 mm Hg and/or DBP \>110 mm Hg. * Current or planned use of nitrates and/or alpha-blockers or other drugs known to affect BP during the study period. * Participants who use PDE5 inhibitors for other indications that cannot or will not refrain from use of PDE5 inhibitors for 7 days before and during their entire period of participation in the study. * History of hypotension, fainting spells, blackouts or autonomic dysfunction, including orthostatic hypotension. * Known diagnosis of secondary hypertension (e.g. Cushing's Disease or hyperaldosteronism, renal fibrodysplasia, renal artery stenosis, etc., clinically significant aortic stenosis etc.). * Recent (within 3 months before the Screening Visit \[Visit S1\]) myocardial infarction; unstable angina leading to hospitalization; uncontrolled, symptomatic atrial fibrillation, or any cardiac arrhythmia that has not been clinically stable for at least 3 months prior to screening. Participants with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months. * Uncontrolled hypothyroidism * Liver disease or dysfunction * Renal dysfunction (\<45 mL/min/1.73mยฒ) or glomerulonephritis * Active infection or major illness * Gastrointestinal conditions or procedures (including weight loss surgery \[eg, Lap-Band or gastric bypass\]) that may affect drug absorption. * Hematologic or coagulation disorders * Active malignancy * Unexplained creatine kinase (CK) \>3 ร— ULN at any time before randomization * A known history of temporary or permanent partial or total vision loss * A known history of "crowded" optic disc. * A known history of retinitis pigmentosa, a rare genetic eye disease. * Any prescription or over-the counter drugs or herbal supplements known to be strong inhibitors of CYP3A4 enzymes * NHYA class III-IV symptoms of heart failure. * History of diabetes or suspected diabetes with glycosylated hemoglobin \> 10% or fasting glucose \>250 mg/dl at Screening Visit (S1).
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What it tests

  • RTN-001
  • Matching placebo control
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Where

34 sites
Retension Clinical Site
Alexander City, United States
Retension Clinical Site
Birmingham, United States
Retension Clinical Site
Tucson, United States
Retension Clinical Site
San Jose, United States
Retension Clinical Site
West Hills, United States
Retension Clinical Site
Waterbury, United States
CRO Call Center
Maitland, United States
Retension Clinical Site
Orlando, United States

โ€ฆand 26 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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