Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
280 (estimated)
Sponsor
Retension Pharmaceuticals. Inc. · Industry
Who this trial is looking for
This trial is looking for adults with high blood pressure that is hard to control. Participants will take either the drug RTN-001 or a placebo (a dummy pill) every day for 12 weeks and visit the clinic for checkups.
Are You a Good Fit for This Trial?
Must be takingAntihypertensive medications
Must not be takingNitratesAlpha-blockers
Rules you outMalignant hypertensionPancreatitis
You may be able to join if
I am between 18 and 70 years old.
I have high blood pressure that remains uncontrolled despite taking at least 2 blood pressure medications.
I have a blood pressure of 130/80 mm Hg or higher.
I am a man or a nonpregnant, nonlactating woman.
I agree to use 2 birth control methods if I am a woman of childbearing potential.
I have a body mass index (BMI) of 18 to 35.
I have not used any illegal drugs within a specific time frame.
You may not be able to join if
I am currently taking part in another clinical trial.
My blood pressure is over 170/110 mm Hg.
I have a history of fainting spells or blackouts.
I have active pancreatitis.
I have a history of drug abuse.
I have uncontrolled hypothyroidism.
I have had a heart attack in the last 3 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.
Trial Locations
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Eligibility Criteria
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 ≥135/80 mm Hg.
* Body mass index of 18 to 35 kg/m2.
Exclusion Criteria:
* Mean seated SBP \>1…
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 ≥135/80 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/1.73m²) 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 × 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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