Trial · NCT04518306
Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension
NCT04518306, 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 Placebo for the Treatment of Hypertension. Trials, record NCT04518306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04518306
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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 Placebo for the Treatment of Hypertension
- NCT number
- NCT04518306
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 755 participants, actual
- Lead sponsor
- George Medicines PTY Limited
- Conditions
- Hypertension
- Interventions
- Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg, Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg, Placebo
- First posted
- 2020-08-19
- Last updated
- 2025-06-03
- Results first posted
- 2025-06-03
Source ClinicalTrials.gov
Registered outcomes21
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 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. |
| Secondary | Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. |
| Secondary | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP\>40mmHg and \<150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 | At Week 4 | The percentage of participants achieving averaged clinic SBP \<140 and DBP \<90 mmHg at Week 4 was evaluated. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 | At Week 4 | The percentage of participants achieving averaged clinic SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated. Participants were analyzed in the treatment group to which they have been randomized. |
| Secondary | Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP\>40mmHg and \<150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. To evaluate the difference in change, least squares mean change value is reported. |
| Secondary | Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Difference in change in trough home SBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication. |
| Secondary | Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Difference in change in trough home DBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication. To evaluate the difference in change, least squares mean change value is reported. |
| Secondary | Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4 | At Week 4 | The percentage of participants achieving home seated mean SBP \<135 and DBP \<85 mmHg at Week 4 was evaluated |
| Secondary | Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 | Randomization to Week 4 | The percentage of participants achieving averaged home seated mean SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
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 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 | At Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have 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 4 | At Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4 | At Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group63
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 4 | Triple ¼ (GMRx2) | -9.6 | Standard Error 1.00 | mmHg | |
| Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Triple ½ (GMRx2) | -10.4 | Standard Error 1.33 | mmHg | |
| Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Placebo | -2.2 | Standard Error 1.16 | mmHg | |
| Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Triple ¼ (GMRx2) | -6.6 | Standard Error 0.94 | mmHg | |
| Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Triple ½ (GMRx2) | -8.2 | Standard Error 1.25 | mmHg | |
| Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Placebo | 1.3 | Standard Error 1.19 | mmHg | |
| Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Triple ¼ (GMRx2) | -3.5 | Standard Error 0.60 | mmHg | |
| Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Triple ½ (GMRx2) | -4.3 | Standard Error 0.93 | mmHg | |
| Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Placebo | 0.5 | Standard Error 0.91 | mmHg | |
| Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 | Triple ¼ (GMRx2) | 73 | Participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Single-Blind Placebo Run-In Period | STARTED | Triple ¼ (GMRx2) | 0 | |
| Single-Blind Placebo Run-In Period | STARTED | Triple ½ (GMRx2) | 0 | |
| Single-Blind Placebo Run-In Period | STARTED | Placebo | 755 | |
| Single-Blind Placebo Run-In Period | COMPLETED | Triple ¼ (GMRx2) | 0 | |
| Single-Blind Placebo Run-In Period | COMPLETED | Triple ½ (GMRx2) | 0 | |
| Single-Blind Placebo Run-In Period | COMPLETED | Placebo | 295 | |
| Single-Blind Placebo Run-In Period | NOT COMPLETED | Triple ¼ (GMRx2) | 0 | |
| Single-Blind Placebo Run-In Period | NOT COMPLETED | Triple ½ (GMRx2) | 0 | |
| Single-Blind Placebo Run-In Period | NOT COMPLETED | Placebo | 460 | |
| Double-Blind Period | STARTED | Triple ¼ (GMRx2) | 113 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events224
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 uric acid increased | Investigations | Triple ¼ (GMRx2) | 2 | 113 | 2 |
| other | Blood uric acid increased | Investigations | Triple ½ (GMRx2) | 5 | 119 | 5 |
| other | Blood uric acid increased | Investigations | Placebo | 1 | 63 | 1 |
| other | Blood uric acid increased | Investigations | Not Randomized | 0 | 460 | 0 |
| other | Blood sodium increased | Investigations | Triple ¼ (GMRx2) | 0 | 113 | 0 |
| other | Blood sodium increased | Investigations | Triple ½ (GMRx2) | 2 | 119 | 2 |
| other | Blood sodium increased | Investigations | Placebo | 1 | 63 | 1 |
| other | Blood sodium increased | Investigations | Not Randomized | 0 | 460 | 0 |
| other | Blood creatinine increased | Investigations | Triple ¼ (GMRx2) | 1 | 113 | 1 |
| other | Blood creatinine increased | Investigations | Triple ½ (GMRx2) | 0 | 119 | 0 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Triple ¼ (GMRx2) | 0 | 113 |
| Total, all-cause mortality | Triple ½ (GMRx2) | 0 | 119 |
| Total, all-cause mortality | Placebo | 0 | 63 |
| Total, all-cause mortality | Not Randomized | 0 | 460 |
| Total, other adverse events | Triple ¼ (GMRx2) | 25 | 113 |
| Total, other adverse events | Triple ½ (GMRx2) | 32 | 119 |
| Total, other adverse events | Placebo | 10 | 63 |
| Total, other adverse events | Not Randomized | 17 | 460 |
| Total, serious adverse events | Triple ¼ (GMRx2) | 0 | 113 |
| Total, serious adverse events | Triple ½ (GMRx2) | 3 | 119 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04518306
GET https://conductscience.org/api/trials/v1/NCT04518306/registered?page=2