Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension

Completed · Phase 3

Conditions studied: Hypertension

In brief

Recent hypertension guidelines recommend combination therapy as initial treatment for many or most patients. Several trials suggest triple low-dose combination therapy may be highly effective in terms of achieving blood pressure (BP) control without increasing adverse effects. This trial is designed to investigate the efficacy and safety of GMRx2 in participants with high blood pressure compared to dual combinations.

Key facts

Study ID

NCT04518293

Run by

George Medicines PTY Limited

People needed

1385

Starts

2021-07-09

Expected to finish

2023-09-01

Last updated by the study team

2025-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At screening visit
• Provided signed consent to participate in the trial.
• Adult of age ≥18 years.
• Attended automated clinic seated mean systolic blood pressure (SBP) (average of last 2 measurements calculated by the device):
• 140-179 mmHg on 0 BP-lowering drugs, or 130-170 mmHg on 1 BP-lowering drug, or 120-160 mmHg on 2 BP-lowering drugs, or 110-150 mmHg on 3 BP-lowering drugs.
• At randomization visit
• Home seated mean SBP 110-154 mmHg in the week prior to the randomization visit.
• Adherence of 80-120% to run-in medication.
• Tolerated run-in medication.
• Adherence to home BP monitoring schedule: in the week before randomization, at least 6 measures (e.g. ≥2 sets of triplicate measures, ≥3 sets of duplicate measures) including at least 1 morning and 1 evening each with ≥2 measures. Morning is defined as any measure in the am and evening as any measure in the pm. Morning and evening do not have to be same day.

You may not qualify if…

• At screening visit
• Receiving 4 or more BP-lowering drugs.
• Receiving any BP lowering drugs for indications other than hypertension e.g. heart failure
• Pregnant or had a positive pregnancy test or unwilling to undertake a pregnancy test during the trial and up to 30 days after the discontinuation of the trial medication or breastfeeding or of childbearing age and not using an acceptable method of contraception. Acceptable methods of birth control include hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method (e.g. condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel), or male partner sterilization. Contraception should be used for at least 1 month before the screening visit and until the end of trial participation.
• Not suitable for participation in a clinical trial according to local ethical or regulatory requirements related to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
• Contraindication, including hypersensitivity (e.g. anaphylaxis or angioedema), to the active run-in treatment or to any of the trial medication options in the four randomized groups.
• Current/history of transient ischemic attack, stroke, or hypertensive encephalopathy.
• Current/history of acute coronary syndrome, unstable angina, myocardial infarction, percutaneous transluminal coronary revascularization, or coronary artery bypass graft.
• Current atrial fibrillation. Patients with a history of paroxysmal atrial fibrillation are potentially eligible as long as there has been no episode in the last 3 months, while patient with a history of persistent or permanent atrial fibrillation are not eligible.
• Current/history of New York Heart Association class III and IV congestive heart failure.
• Current/history of a known secondary cause of hypertension, such as primary aldosteronism, renal artery stenosis, pheochromocytoma, or Cushing's syndrome.
• Current/history of substantially uncontrolled diabetes (HbA1c > 11.0%) within last three months.
• Current/history of end-stage renal disease or anuria or estimated glomerular filtration rate (eGFR) <60 ml/min/1.73m2.
• Electrolyte levels that would be regarded as contraindications for any of the potential treatment arms e.g. serum sodium <132mmol/l or >148mmol/l serum potassium <3.1 mmol/l or >5.6 mmol/l.
• Current/history of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the upper limit of normal range within 6 months.
• Current concomitant illness or physical impairment or mental condition that in the judgment of the investigator could interfere with the effective conduct of the trial or constitutes a significant risk to the participants' well-being.
• Arm circumference that is too large (>55 cm) or too small (<15-24 cm) to allow accurate measurement of BP.
• Currently taking or might need during the trial, a concomitant treatment which is known to interact with one or more of the trial medications: digoxin, lithium, diabetics receiving aliskiren, moderate and strong CYP3A4 inhibitors (e.g. ritonavir, ketoconazole, diltiazem], simvastatin >20 mg/day, immunosuppressants.
• Might need treatment with drugs that are prohibited during the trial: other antihypertensive drugs, endothelin receptor antagonists, neprilysin inhibitors, or other drugs that may affect BP.
• Current surgical or medical condition that might significantly alter the absorption, distribution, metabolism, or excretion of trial drugs such as prior major gastrointestinal tract surgery (e.g. gastrectomy, lap band, or bowel resection) or acute flare of inflammatory bowel disease within one year.
• Individuals working >2 nightshifts per week.
• Participated in any investigative drug or device trial within the previous 30 days.
• History of alcohol or drug abuse within 12 months.
• At randomization visit
• Unable to adhere to the trial procedures during the run-in treatment period.

Where it is running

• Headlands Research — Scottsdale, Arizona, United States
• Quality of Life Medical & Research Associates — Tucson, Arizona, United States
• Valiance Clinical Research — South Gate, California, United States
• Valiance Clinical Research — Tarzana, California, United States
• Clinical Research of Brandon — Brandon, Florida, United States
• Inpatient Research Clinic — Hialeah, Florida, United States
• Multi-Speciality Research Associates — Lake City, Florida, United States
• Suncoast Research Group — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• Ocala Research Institute — Ocala, Florida, United States
• Suncoast Research Associates — St. Petersburg, Florida, United States
• Accel Research — St. Petersburg, Florida, United States
• Precision Research Center — Tampa, Florida, United States
• Meridian Clinical Research — Savannah, Georgia, United States
• Buckhead Primary Care Research — Snellville, Georgia, United States
• Loyola University — Maywood, Illinois, United States
• Meridian Clinical Research — Baton Rouge, Louisiana, United States
• Meridian Clinical Research — Endwell, New York, United States
• Javarra Research — Charlotte, North Carolina, United States
• East Carolina University — Greenville, North Carolina, United States
• The University of Tennessee Health Science Center — Memphis, Tennessee, United States
• ACRC Trials - Southwest Medical Village — Austin, Texas, United States
• ACRC Trials - Premier Family Physicians — Austin, Texas, United States
• ACRC Trials - Family Medicine Associates of Texas — Carlton, Texas, United States
• Elite Clinical Studies — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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