Value of Liquid Potassium Magnesium Citrate in Controlling Hypertension

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Liquid potassium-magnesium citrate (KMgCit) as a pharmaceutical formulation will lower blood pressure among patients with pre- or Stage I hypertension on their customary diet.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meta Pharm Development, LLC; University of Texas Southwestern Medical Center
• Collaborator: University of Texas Southwestern Medical Center
• Treatments: Citric Acid; Magnesium citrate; Potassium Citrate; Sodium Citrate

Criteria

Inclusion Criteria:

• Men or women > 21 years of age

• Any Race/Ethnicity

• Pre- or Stage I hypertension (BP >= 120/80 and <= 159/99)

Exclusion Criteria:

• Diabetes mellitus

• Renal impairment (serum creatinine > 1.4 mg/dL)

• Any heart diseases such as congestive heart failure or sustained arrhythmia

• Chronic NSAID use

• Treatment with diuretics

• Gastroesophageal reflux disease (GERD) requiring treatment with acid reducing agents or antacid more than once a week

• Esophageal-gastric ulcer

• Chronic diarrhea

• Hyperkalemia (serum > 4.6 meq/L for patients on angiotension-converting-enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), serum K > 5.0 meq/L for patient not on ACE inhibitors or ARBs)

• Abnormal liver function test (aspartate transaminase (AST) or alanine transaminase (ALT) above upper limit of normal range)

• Subjects who require any potassium supplement on a regular basis from any reasons

• Pregnancy

• History of major depression, bipolar disorder, or schizophrenia