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Vasodilator

MANP for Hypertension (DTC/RHS Trial)

Phase 1
Waitlist Available
Research Sponsored by E-Star BioTech, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 months.
Awards & highlights

DTC/RHS Trial Summary

A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods. Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort. Endpoints not related to the safety reviews will be analyzed after the last patient last visit (LPLV).

Eligible Conditions
  • High Blood Pressure (Hypertension)
  • Hypertension

DTC/RHS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Abbreviated Neurological Examination
Adverse Events
Blood Pressure
+25 more
Secondary outcome measures
Aldosterone
Cardiac Metrics
Cardiac Metrics: Blood pressures
+8 more

DTC/RHS Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MANPExperimental Treatment1 Intervention
Subjects randomized to the experimental arm, will receive a single subcutaneous injection each morning daily. (multiple ascending dose cohorts) Intervention: Drug: MANP
Group II: Placebo ComparatorPlacebo Group1 Intervention
Subjects randomized to the placebo arm, will receive a single subcutaneous injection each morning daily. Intervention: Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MANP
2017
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

Mayo ClinicOTHER
3,207 Previous Clinical Trials
3,766,823 Total Patients Enrolled
49 Trials studying Hypertension
46,941 Patients Enrolled for Hypertension
IntegriumIndustry Sponsor
25 Previous Clinical Trials
5,238 Total Patients Enrolled
3 Trials studying Hypertension
1,217 Patients Enrolled for Hypertension
E-Star BioTech, LLCLead Sponsor
1 Previous Clinical Trials
132 Total Patients Enrolled
1 Trials studying Hypertension
132 Patients Enrolled for Hypertension

Frequently Asked Questions

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~11 spots leftby Apr 2025