RECRUITING

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

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Conditions

Difficult to Control HypertensionResistant Hypertension

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE TITRATION, MULTI-CENTER STUDY to EVALUATE the SAFETY and EFFICACY of SUBCUTANEOUS MANP WHEN ADMINISTERED ONCE DAILY for 42 DAYS in PARTICIPANTS with DIFFICULT to CONTROL HYPERTENSION/RESISTANT HYPERTENSION

Quick Facts

Study Start:2024-11
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06343298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female subjects aged 18 - 80 years, inclusive, at the screening visit.
  2. * Female subjects must not be of childbearing potential
  3. * 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.
  4. * Subjects must have a seated (5 minutes) systolic blood pressure ≥ 140 mmHg and SBP ≥135 mmHg by ABPM prior to randomization (T1).
  5. * Subjects must have a CKD-EPI eGFR ≥ 30 mL/min/1.73m2
  6. * 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.
  7. * Subjects must have a BMI between 18 - 40 kg/m2.
  8. * Subjects who engage in sexual intercourse in which their partner could become pregnant must agree to use a barrier method of birth control (i.e., vaginal/penile condom) with spermicide for the duration of the study and for 90 days after the last dose of study drug or be at least 6 weeks post-vasectomy with confirmation by post-vasectomy semen analysis. In addition, subjects may not donate sperm for the duration of the study and for 90 days after the last dose of study drug.
  1. * Subjects with an average sitting systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg at Screening (SV), or prior to randomization at T1.
  2. * Subjects with a history of secondary hypertension, including but not limited to coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, Cushing's disease, pheochromocytoma, and polycystic kidney disease. If the subject has not previously been evaluated for secondary hypertension, investigators are responsible for evaluating all potential secondary causes of hypertension in accordance with current practices and clinical guidelines before entering the patient into the study.
  3. * Subjects with an HbA1c ≥ 8% at screening (SV)
  4. * Subjects who have experienced myocardial infarction, unstable angina, or a cerebrovascular accident (CVA) within 6 months of the Screening Visit; or sick sinus syndrome or second- or third-degree atrioventricular block, or recurrent atrial tachyarrhythmia, recurrent ventricular tachycardia, or symptomatic bradycardia.
  5. * Subjects who have an implanted cardioverter defibrillator (ICD) that has been fired for any arrhythmia within 3 months of Screening (SV) or implanted pacemakers.
  6. * Subjects with congestive heart failure (New York Heart Association \[NYHA\] class II-IV)
  7. * Subjects with hemodynamically significant valvular heart disease
  8. * Subjects undergoing hemodialysis or peritoneal dialysis, or history of renal transplant.
  9. * Subjects who have diagnosis or recurrence of malignancy within the past 3 years
  10. * Subjects with a documented history of sleep apnea, with a prescription for CPAP therapy.
  11. * Women of childbearing potential
  12. * Subjects who are pregnant or breastfeeding

Contacts and Locations

Study Contact

Seetha R Iyer, MS
CONTACT
212-271-4295
sri@icw.ventures
Lucia Gonzalez
CONTACT

Principal Investigator

David Smith, MD
STUDY_DIRECTOR
E-Star BioTech, LLC

Study Locations (Sites)

Orange County Research Center
Lake Forest, California, 92630
United States
Interventional Cardiology Medical Group
West Hills, California, 91308
United States

Collaborators and Investigators

Sponsor: E-Star BioTech, LLC

  • David Smith, MD, STUDY_DIRECTOR, E-Star BioTech, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2024-11
Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

  • Resistant Hypertension

Additional Relevant MeSH Terms

  • Difficult to Control Hypertension