Is NCT07142356 recruiting in Lawrenceville, GA?

Yes, NCT07142356 is currently recruiting participants at its Lawrenceville, GA location. This uncontrolled hypertension clinical trial is actively enrolling qualified participants.

How do I join the uncontrolled hypertension clinical trial in Lawrenceville?

To join this clinical trial in Lawrenceville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Lawrenceville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Uncontrolled Hypertension Clinical Trial in Lawrenceville, GA

About This Uncontrolled Hypertension Study in Lawrenceville

The goal of this clinical trial is to learn if the drug RT-001 works to reduce high blood pressure (hypertension) in adults. It will also learn about the safety of RTN-001. The main questions it aims to answer are: Does RTN-001 lower blood pressure in patients who have uncontrolled hypertension? What medical problems do participants have when taking RTN-001? Researchers will compare RTN-001 to a placebo (a look-alike substance that contains no drug) to see if RTN-001 works to treat uncontrolled hypertension. Participants will: Take RTN-001 or a placebo every day for 12 weeks Visit the clinic about once every 2 weeks for checkups and tests Keep a diary of their symptoms and all medications that they take including RTN-001

Sponsor: Retension Pharmaceuticals. Inc.

Who Can Participate

Inclusion Criteria

Provision of written informed consent before any study-specific procedure.

Male or female patients age 18 to 70 years, inclusive, at the Screening Visit.

Uncontrolled HTN despite being on a stable regimen of ≥ 2 antihypertensive medications in the following drug classes: ACE-inhibitors, ARBs, beta blockers, calcium channel blockers, mineralocorticoid receptor antagonists, or diuretics. A stable regimen is defined as being on the same medications and the same dose for at least 30 days before screening. A combination pill containing 2 separate classes of antihypertensive drugs is considered 2 antihypertensive medications.

Mean BP of ≥ 130/80 mm Hga.

Men and nonpregnant, nonlactating women. Women must be either:

Naturally postmenopausal defined as ≥ 1 year without menses and follicle-stimulating hormone ≥ 40.0 IU/L, or

Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or Women of childbearing potential must be willing to use 2 acceptable methods of birth control (unless they have agreed to follow the definition of true abstinence). The minimal requirement for adequate contraception should be started the day of Visit T1 (Day 1), continuing during the Treatment Period and for at least 30 days after the last dose of study drug. Acceptable methods of birth control include:

Oral, implantable, injectable, or topical birth control medications. Note: Oral birth control medication must be started ≥ 30 days before the first dose of treatment in the Placebo Run-in.

Placement of an intrauterine device with or without hormones.

Barrier methods including condom or occlusive cap with spermicidal foam or spermicidal jelly.

Vasectomized male partner who is the sole partner for this patient.

True abstinence when this is the preferred and usual lifestyle of the patient. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception.

Body mass index of 18 to 35 kg/m2.

Negative prestudy urine drugs of abuse screen (with the exception of tetrahydrocannabinol \[THC\]).

If taking a PDE5 inhibitor for erectile dysfunction, must be willing to pause use during the study period. Only patients with uncontrolled HTN on ≥ 2 accepted classes of antihypertensive drugs who continue to satisfy the inclusion criteria above, are \> 80% compliant during the Placebo Run-in dosing of 3 tablets QD of single-blind placebo and have successfully completed the baseline 24 hour ABPM will be randomly assigned to treatment with RTN-001 or matching placebo. aThe initial BP inclusion criterion will be ≥ 130/80 mm Hg. After approximately 25% of patients (80 patients) have been randomly assigned to study treatment, the actual baseline BP of randomized patients will be reviewed to ensure target distribution of BP at study entry. If the mean baseline SBP is not within the target range of approximately 145 mm Hg, the inclusion criterion may be modified to reflect a higher BP inclusion criterion.

Exclusion Criteria

Currently enrolled in a study with an investigational product or any other type of medical research within 30 days before randomization.

Mean seated SBP \> 170 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 (except for those allowed in the protocol; Section 5.9.2) including SGLT2 inhibitors and GLP-1 agonists.

Regular user of PDE5 inhibitors or cannot/is unwilling to refrain from use of PDE5 inhibitors for 7 days before and during their participation in the study.

History of hypotension, fainting spells, or blackouts, including orthostatic hypotension.

Malignant HTN, primary aldosteronism, or secondary HTN.

Active pancreatitis.

A history of drug abuse.

Abuses alcohol defined as average weekly intake greater than 21 units for males or 14 units for females. One unit is equivalent to a 12 oz beer, 1 measure of spirits, or 1 glass of wine.

History or presence of gastrointestinal, hepatic, or renal disease or other conditions that would be known to interfere with the absorption, distribution, metabolism, or excretion of drugs.

Recent (within 3 months before the Screening Visit \[Visit S1\]) myocardial infarction; unstable angina leading to hospitalization; uncontrolled, symptomatic cardiac arrhythmia (or medication for an arrhythmia that was started or dose changed within 3 months of screening); coronary artery bypass graft; percutaneous coronary intervention; carotid surgery or stenting; cerebrovascular accident; transient ischemic attack; endovascular procedure or surgical intervention for peripheral vascular disease; or plans to undergo a major surgical or interventional procedure (eg, percutaneous coronary intervention, coronary artery bypass graft, carotid or peripheral revascularization). Patients 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, including thyroid-stimulating hormone \> 1.5 × the upper limit of normal (ULN) at the Screening Visit (Visit S1); patients stabilized on thyroid replacement therapy for at least 6 weeks before randomization are allowed.

Liver disease or dysfunction, including:

Positive serology for hepatitis B surface antigen and/or hepatitis C antibodies at the Screening Visit (Visit S1), or

Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≥ 2 × ULN, and/or total bilirubin (TB) ≥ 2 × ULN at the Screening Visit (Visit S1). If TB ≥ 1.2 × ULN, a reflex indirect (unconjugated) bilirubin will be obtained, and if consistent with Gilbert's syndrome or if the patient has a history of Gilbert's syndrome, the patient may be enrolled in the study. Note: At the discretion of the Investigator, a repeat of ALT and/or AST may be completed before randomization. For those patients who have a repeat ALT and/or AST, the repeat value will be used to determine eligibility. Also, if the patient tests positive for the hepatitis C antibody, but the optional reflexive test for hepatitis C RNA is negative, the patient can be enrolled.

Renal dysfunction or glomerulonephritis, including estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) formula \< 45 mL/min/1.73 m2 at the Screening Visit (Visit S1). Note: a single repeat qualifying eGFR, performed at the discretion of the Investigator, is acceptable.

Gastrointestinal conditions or procedures (including weight loss surgery \[eg, Lap-Band or gastric bypass\] that may affect drug absorption.

Hematologic or coagulation disorders or a hemoglobin level \< 10.0 g/dL at the Screening Visit (Visit S1).

Active malignancy, including a malignancy requiring surgery, chemotherapy, and/or radiation in the 5 years before Screening. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed.

Unexplained creatine kinase (CK) \> 3 × ULN at any time before randomization, which is not associated with recent trauma or physically strenuous activity. Patients with an explained CK elevation must have a single repeat CK ≤ 3 × ULN before randomization.

Blood donation, participation in multiple blood draws, clinical study, major trauma, blood transfusion, or surgery with or without blood loss within 30 days before randomization.

Use of any experimental or investigational drug(s) within 30 days before Screening.

An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-investigator, or any Sponsor personnel

Is considered to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of study outcomes by the Investigator, after reviewing the medical and psychiatric history, physical examination, and laboratory evaluation.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Lawrenceville?

Yes, this clinical trial (NCT07142356) has an active research site in Lawrenceville, GA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Uncontrolled Hypertension Treatment Options in Lawrenceville, GA

If you're searching for uncontrolled hypertension treatment options in Lawrenceville, GA, this clinical trial (NCT07142356) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Lawrenceville research site is actively enrolling participants for this clinical trial. You'll receive care from experienced uncontrolled hypertension specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all uncontrolled hypertension clinical trials near you to find additional studies recruiting in your area.

Uncontrolled Hypertension Clinical Trial in Lawrenceville, GA

Expert Care in Lawrenceville

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