MedTrace Logo

Safety Study of RMJH-111b to Treat Essential Hypertension

NCT02822222 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-09-23

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to evaluate the safety of RMJH-111b, including how well it is tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension. The study also measured the amount of magnesium in the blood and urine before and after RMJH-111b administration to evaluate what the body does to RMJH-111b (pharmacokinetics).

Conditions

  • Essential Hypertension

Interventions

DRUG

Magnesium citrate, tribasic anhydrous soft gelatin capsule

110 mg elemental magnesium/capsule

DRUG

Placebo soft gelatin capsule

0 mg elemental magnesium/capsule

Sponsors & Collaborators

  • RMJ Holdings, LLC

    lead INDUSTRY

Principal Investigators

  • Joel M Neutel, MD · Orange County Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-10
Primary Completion
2016-07-07
Completion
2016-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02822222 on ClinicalTrials.gov