Trial · NCT04518293
Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
NCT04518293, Phase 3, Completed, George Medicines PTY Limited; results first posted 2025-06-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension. Trials, record NCT04518293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04518293
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
- NCT number
- NCT04518293
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,385 participants, actual
- Lead sponsor
- George Medicines PTY Limited
- Conditions
- Hypertension
- Interventions
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg, telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg, Telmisartan 20 mg/amlodipine 2.5 mg, telmisartan 40 mg/amlodipine 5 mg, Telmisartan 20 mg/indapamide 1.25 mg, telmisartan 40 mg/indapamide 2.5 mg, Amlodipine 2.5 mg/indapamide 1.25 mg, amlodipine 5 mg/indapamide 2.5 mg
- First posted
- 2020-08-19
- Last updated
- 2025-06-03
- Results first posted
- 2025-06-03
- Limitations and caveats
The trial included comparatively few participants with very high levels of blood pressure (BP), which makes direct comparison with previous trials challenging. The trial design did not allow a direct randomized comparison between ½ dose and standard dose combinations, or with other drugs and doses that are in common use. The option of non-uptitration after 6 weeks of half-dose regimens likely led to underestimation of the difference between standard dose regimens.
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Week 12 | The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis. |
| Secondary | Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Week 12 | Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. |
| Secondary | Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6 | Week 6 | Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. |
| Secondary | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12 | Week 12 | Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. |
| Secondary | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6 | Week 6 | Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12 | Week 12 | The percentage of participants achieving averaged clinic SBP \<140 mmHg and DBP \<90 mmHg at Week 12 was evaluated. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6 | Week 6 | The percentage of participants achieving averaged clinic SBP \<140 mmHg and DBP \<80 mmHg at Week 6 was evaluated. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12 | Week 12 | The percentage of participants achieving averaged clinic SBP \<130 mmHg and DBP \<80 mmHg at Week 12 was evaluated. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6 | Week 6 | The percentage of participants achieving averaged clinic SBP \<130 mmHg and DBP \<80 mmHg at Week 6 was evaluated. |
| Secondary | Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6 | Week 6 | Difference in change in average home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Week 12 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Week 12 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6 | Week 6 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12 | Week 12 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6 | Week 6 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12 | Week 12 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6 | Week 6 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12 | Week 12 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6 | Week 6 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6 | Week 6 | Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized. | mmHg | LEAST_SQUARES_MEAN |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group160
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | GMRx2 | -4.0 | Standard Error 0.45 | mmHg | |
| Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Dual - TA | 1.4 | Standard Error 0.60 | mmHg | |
| Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Dual - TI | -1.5 | Standard Error 0.51 | mmHg | |
| Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Dual - AI | 0.4 | Standard Error 0.62 | mmHg | |
| Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | GMRx2 | -5.5 | Standard Error 0.55 | mmHg | |
| Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Dual - TA | 0.1 | Standard Error 0.85 | mmHg | |
| Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Dual - TI | -1.2 | Standard Error 1.02 | mmHg | |
| Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12 | Dual - AI | 0.9 | Standard Error 0.86 | mmHg | |
| Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6 | GMRx2 | -0.8 | Standard Error 0.50 | mmHg | |
| Difference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6 | Dual - TA | 4.2 | Standard Error 0.88 | mmHg |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single, Active run-in (4 Weeks) | STARTED | GMRx2 | 2,244 | |
| Single, Active run-in (4 Weeks) | STARTED | Dual - TA | 0 | |
| Single, Active run-in (4 Weeks) | STARTED | Dual - TI | 0 | |
| Single, Active run-in (4 Weeks) | STARTED | Dual - AI | 0 | |
| Single, Active run-in (4 Weeks) | COMPLETED | GMRx2 | 1,385 | |
| Single, Active run-in (4 Weeks) | COMPLETED | Dual - TA | 0 | |
| Single, Active run-in (4 Weeks) | COMPLETED | Dual - TI | 0 | |
| Single, Active run-in (4 Weeks) | COMPLETED | Dual - AI | 0 | |
| Single, Active run-in (4 Weeks) | NOT COMPLETED | GMRx2 | 859 | |
| Single, Active run-in (4 Weeks) | NOT COMPLETED | Dual - TA | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events285
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Blood glucose increased | Investigations | Not Randomized | 0 | 859 | |
| other | Blood glucose increased | Investigations | GMRx2 | 42 | 551 | |
| other | Blood glucose increased | Investigations | Dual - TA | 15 | 282 | |
| other | Blood glucose increased | Investigations | Dual - TI | 19 | 276 | |
| other | Blood glucose increased | Investigations | Dual - AI | 26 | 276 | |
| other | Blood uric acid increased | Investigations | Not Randomized | 0 | 859 | |
| other | Blood uric acid increased | Investigations | GMRx2 | 37 | 551 | |
| other | Blood uric acid increased | Investigations | Dual - TA | 9 | 282 | |
| other | Blood uric acid increased | Investigations | Dual - TI | 19 | 276 | |
| other | Blood uric acid increased | Investigations | Dual - AI | 23 | 276 |
1 to 10 of 285Source ClinicalTrials.gov
See all 285 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Not Randomized | 0 | 859 |
| Total, all-cause mortality | GMRx2 | 0 | 551 |
| Total, all-cause mortality | Dual - TA | 0 | 282 |
| Total, all-cause mortality | Dual - TI | 0 | 276 |
| Total, all-cause mortality | Dual - AI | 0 | 276 |
| Total, other adverse events | Not Randomized | 136 | 859 |
| Total, other adverse events | GMRx2 | 306 | 551 |
| Total, other adverse events | Dual - TA | 139 | 282 |
| Total, other adverse events | Dual - TI | 142 | 276 |
| Total, other adverse events | Dual - AI | 136 | 276 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39426836 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04518293
GET https://conductscience.org/api/trials/v1/NCT04518293/registered?page=2