Phase 3
N=755
Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT04518306 ↗Enrolled (actual)
755
Serious AEs
0.9%
Results posted
Jun 2025
Primary outcome: Primary: Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 — -9.6; -10.4; -2.2 mmHg — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg (Drug); Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- George Medicines PTY Limited
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 |
-9.6; -10.4; -2.2 | <0.0001 sig |
| SECONDARY Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 |
-6.6; -8.2; 1.3 | <0.0001 sig |
| SECONDARY Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 |
-3.5; -4.3; 0.5 | 0.0015 sig |
| SECONDARY Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 |
73; 83; 23 | 0.0002 sig |
| SECONDARY Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 |
23; 36; 2 | <0.0001 sig |
| SECONDARY Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 |
-5.1; -6.6; -1.1 | 0.0002 sig |
| SECONDARY Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 |
-8.1; -10.1; -1.3 | 0.0003 sig |
| SECONDARY Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 |
-4.2; -5.7; -0.3 | 0.0003 sig |
| SECONDARY Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4 |
67; 64; 15 | <0.0001 sig |
| SECONDARY Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 |
32; 40; 7 | 0.0030 sig |
Summary
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 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 placebo.
Eligibility Criteria
Inclusion Criteria
At screening visit:
- Provided signed consent to participate in the trial.
- Adult aged ≥18 years.
- Low calculated CV risk according to local guidelines such that pharmacological BP-lowering treatment is not mandatory: e.g. Pooled Cohorts Equation 10-years ASCVD risk 11.0%) within last three months.
- Current/history of end-stage renal disease or anuria or estimated glomerular filtration rate (eGFR) 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 ( 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 (see Error! Reference source not found.).
- 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-night shifts per week.
- Participated in any investigational 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 period.
- Any of the following which in the investigator's judgment may compromise the safety of the participant if randomized to the trial medications:
- High or low clinic BP levels even in the light of the values for home BP that are available for that participant. The exact levels of BP are not specified, since there is clinical uncertainty as to the relevance of BP levels which are high/low in clinic only; for example the clinical relevance of 'whitecoat hypertension' is uncertain.
- High or low home DBP levels. The exact levels of DBP are not specified, reflecting clinical uncertainty of for example isolated diastolic hypertension. However, home DBP values of >99 mmHg may typically be considered as requiring treatment intensification, and such participants would not be suitable for randomization.
- Any abnormal laboratory value which 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.
- Fulfilling any of the exclusion criteria mentioned for the screening visit, when verified again at randomization visit.
Data sourced from ClinicalTrials.gov (NCT04518306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.