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NCT06343298RECRUITINGIRB Ready

To Evaluate the Safety and Efficacy of MANP in Subjects With Difficult to Control/ Resistant Hypertension

(BOLD-HTN)

Sponsored by E-Star BioTech, LLC

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 120 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is a Phase 2 dose-titration study designed to evaluate the safety and efficacy of MANP subcutaneous injection compared to placebo in reducing baseline daytime systolic blood pressure (SBP), derived from 24-hour ambulatory blood pressure monitoring (ABPM), in subjects with hypertension who are taking 3 or more antihypertensive medications with different mechanisms of action.

Who Can Participate

Inclusion Criteria

Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening:
Male or female subjects aged 18 - 80 years, inclusive, at the screening visit.
Female subjects must not be of childbearing potential
Subjects must be taking appropriate doses of 3 or more antihypertensive drugs with different mechanisms of action. One of which must be a diuretic and the other must be an ACEi or ARB at atleast 50% of the maximum recommended dose for hypertension.
Subjects must have a seated (5 minutes) systolic blood pressure โ‰ฅ 140 mmHg and SBP โ‰ฅ135 mmHg by ABPM prior to randomization (T1).
Subjects must have a CKD-EPI eGFR โ‰ฅ 30 mL/min/1.73m2
A subset of the subjects with an eGFR between 20-30 ml/min/1.73m2 will be included, not to exceed 10% of the total study subjects.
Subjects must have a BMI between 18 - 40 kg/m2.
Subjects who engage in sexual intercourse in which their partner could become pregnant must agree

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

120 participants

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Age Range

18 Years - 80 Years

โšง

Gender

ALL

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Sponsor

E-Star BioTech, LLC

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Beverly Hills

California

Location available
View Beverly Hills location page
RECRUITING

Granada Hills

California

Location available
View Granada Hills location page
RECRUITING

Lake Forest

California

Location available
View Lake Forest location page
RECRUITING

Palmdale

California

Location available
View Palmdale location page
RECRUITING

Valencia

California

Location available
View Valencia location page
WITHDRAWN

West Hills

California

Location available
View West Hills location page
RECRUITING

Westlake Village

California

Location available
View Westlake Village location page
RECRUITING

Biscayne Park

Florida

Location available
View Biscayne Park location page

๐Ÿ“ And 20 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

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

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Resistant Hypertension Treatment in Beverly Hills?

Join others in California exploring innovative treatment options through clinical research

Resistant Hypertension Treatment Options in Beverly Hills, California

If you're searching for Resistant Hypertension treatment in Beverly Hills, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Beverly Hills, Granada Hills, Lake Forest and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Resistant Hypertension. All study-related care is provided at no cost to participants.

Local Sites
3 locations in California
Now Enrolling
Up to 120 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Resistant Hypertension?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Resistant Hypertension

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Resistant Hypertension Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06343298. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.