Trial Outcomes & Findings for Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension (NCT NCT04518306)

Last Updated: 2025-06-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

755 participants

Primary outcome timeframe

Randomization to Week 4

Results posted on

2025-06-03

Participant Flow

The trial was conducted at 47 trial centers spread across 5 countries (United States of America \[USA\] 23, Great Britain 10, Sri Lanka 7, Australia 5, and Nigeria 2).

Out of 1584 participants screened, 755 participants entered the 2-week single-blind placebo run-in period. Overall, 460 of the 755 participants who entered the run-in period were not randomized, the most common reason was failure to meet the criteria of home seated mean SBP of 130-154 mmHg in the week prior to the randomization visit. Total of 295 participants were randomized to the treatment groups at the end of run-in period.

Participant milestones

Participant milestones
Measure	Triple ¼ (GMRx2) Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Single-Blind Placebo Run-In Period STARTED	0	0	755
Single-Blind Placebo Run-In Period COMPLETED	0	0	295
Single-Blind Placebo Run-In Period NOT COMPLETED	0	0	460
Double-Blind Period STARTED	113	119	63
Double-Blind Period COMPLETED	91	91	50
Double-Blind Period NOT COMPLETED	22	28	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Triple ¼ (GMRx2) Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Double-Blind Period Run in failure	0	0	1
Double-Blind Period Adverse Event	0	2	2
Double-Blind Period Lost to Follow-up	1	2	2
Double-Blind Period Participant moved to open-label extension (OLE) study	21	21	8
Double-Blind Period Other	0	2	0
Double-Blind Period Missing	0	1	0

Baseline Characteristics

Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.	Total n=295 Participants Total of all reporting groups
Region of Enrollment Sri Lanka	19 Participants n=5 Participants	18 Participants n=7 Participants	6 Participants n=5 Participants	43 Participants n=4 Participants
Region of Enrollment United Kingdom	18 Participants n=5 Participants	15 Participants n=7 Participants	10 Participants n=5 Participants	43 Participants n=4 Participants
Age, Continuous	49.5 years STANDARD_DEVIATION 12.25 • n=5 Participants	51.2 years STANDARD_DEVIATION 9.88 • n=7 Participants	50.9 years STANDARD_DEVIATION 12.81 • n=5 Participants	50.5 years STANDARD_DEVIATION 11.47 • n=4 Participants
Sex: Female, Male Female	68 Participants n=5 Participants	61 Participants n=7 Participants	36 Participants n=5 Participants	165 Participants n=4 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	58 Participants n=7 Participants	27 Participants n=5 Participants	130 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	40 Participants n=5 Participants	42 Participants n=7 Participants	23 Participants n=5 Participants	105 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants	76 Participants n=7 Participants	38 Participants n=5 Participants	184 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	27 Participants n=7 Participants	8 Participants n=5 Participants	61 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	20 Participants n=7 Participants	11 Participants n=5 Participants	49 Participants n=4 Participants
Race (NIH/OMB) White	66 Participants n=5 Participants	72 Participants n=7 Participants	43 Participants n=5 Participants	181 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	59 Participants n=5 Participants	65 Participants n=7 Participants	33 Participants n=5 Participants	157 Participants n=4 Participants
Region of Enrollment Australia	15 Participants n=5 Participants	16 Participants n=7 Participants	11 Participants n=5 Participants	42 Participants n=4 Participants
Region of Enrollment Nigeria	2 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Height	165.97 cm STANDARD_DEVIATION 10.439 • n=5 Participants	166.68 cm STANDARD_DEVIATION 10.247 • n=7 Participants	167.36 cm STANDARD_DEVIATION 9.878 • n=5 Participants	166.55 cm STANDARD_DEVIATION 10.223 • n=4 Participants
Weight	85.50 kg STANDARD_DEVIATION 20.865 • n=5 Participants	85.12 kg STANDARD_DEVIATION 22.419 • n=7 Participants	84.92 kg STANDARD_DEVIATION 20.299 • n=5 Participants	85.22 kg STANDARD_DEVIATION 21.319 • n=4 Participants
BMI	30.9 kg/m^2 STANDARD_DEVIATION 6.04 • n=5 Participants	30.4 kg/m^2 STANDARD_DEVIATION 6.69 • n=7 Participants	30.0 kg/m^2 STANDARD_DEVIATION 5.67 • n=5 Participants	30.5 kg/m^2 STANDARD_DEVIATION 6.22 • n=4 Participants
Smoking - Never	90 Participants n=5 Participants	79 Participants n=7 Participants	47 Participants n=5 Participants	216 Participants n=4 Participants
Smoking - Ex-smoker	15 Participants n=5 Participants	28 Participants n=7 Participants	12 Participants n=5 Participants	55 Participants n=4 Participants
Smoking - Current smoker	8 Participants n=5 Participants	12 Participants n=7 Participants	4 Participants n=5 Participants	24 Participants n=4 Participants
Alcohol consumption - Currently drink alcohol once a week or more	38 Participants n=5 Participants	50 Participants n=7 Participants	25 Participants n=5 Participants	113 Participants n=4 Participants
Pre-screening 12-lead ECG - Normal	83 Participants n=5 Participants	87 Participants n=7 Participants	47 Participants n=5 Participants	217 Participants n=4 Participants
Pre-screening 12-lead ECG - Any other abnormalities	30 Participants n=5 Participants	32 Participants n=7 Participants	16 Participants n=5 Participants	78 Participants n=4 Participants
Education - No formal education	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Education - Primary school	7 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	20 Participants n=4 Participants
Education - Secondary school	33 Participants n=5 Participants	39 Participants n=7 Participants	13 Participants n=5 Participants	85 Participants n=4 Participants
Education - Tertiary school	52 Participants n=5 Participants	57 Participants n=7 Participants	39 Participants n=5 Participants	148 Participants n=4 Participants
Vocational training	21 Participants n=5 Participants	15 Participants n=7 Participants	5 Participants n=5 Participants	41 Participants n=4 Participants

PRIMARY outcome

Timeframe: Randomization to Week 4

Population: 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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4	-9.6 mmHg Standard Error 1.00	-10.4 mmHg Standard Error 1.33	-2.2 mmHg Standard Error 1.16

SECONDARY outcome

Timeframe: Randomization to Week 4

Population: 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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4	-6.6 mmHg Standard Error 0.94	-8.2 mmHg Standard Error 1.25	1.3 mmHg Standard Error 1.19

SECONDARY outcome

Timeframe: Randomization to Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4	-3.5 mmHg Standard Error 0.60	-4.3 mmHg Standard Error 0.93	0.5 mmHg Standard Error 0.91

SECONDARY outcome

Timeframe: At Week 4

Population: 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.

The percentage of participants achieving averaged clinic SBP \<140 and DBP \<90 mmHg at Week 4 was evaluated.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4	73 Participants	83 Participants	23 Participants

SECONDARY outcome

Timeframe: At Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4	23 Participants	36 Participants	2 Participants

SECONDARY outcome

Timeframe: Randomization to Week 4

Population: 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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4	-5.1 mmHg Standard Error 0.76	-6.6 mmHg Standard Error 0.60	-1.1 mmHg Standard Error 0.79

SECONDARY outcome

Timeframe: Randomization to Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4	-8.1 mmHg Standard Error 1.24	-10.1 mmHg Standard Error 1.36	-1.3 mmHg Standard Error 1.24

SECONDARY outcome

Timeframe: Randomization to Week 4

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4	-4.2 mmHg Standard Error 0.83	-5.7 mmHg Standard Error 0.65	-0.3 mmHg Standard Error 0.93

SECONDARY outcome

Timeframe: At Week 4

Population: 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.

The percentage of participants achieving home seated mean SBP \<135 and DBP \<85 mmHg at Week 4 was evaluated

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4	67 Participants	64 Participants	15 Participants

SECONDARY outcome

Timeframe: Randomization to Week 4

Population: 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.

The percentage of participants achieving averaged home seated mean SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4	32 Participants	40 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to Week 4

Population: Analysis was done on safety population. The Safety Set is defined as all participants who took at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety endpoints, participants were analyzed in the treatment group they actually received. One participant each from Triple ½ (GMRx2) and Placebo group did not receive randomly assigned treatment during "Randomization to Week 4" period.

The primary safety outcome is percentage of participants discontinued trial medication due to an Adverse Event (AE) or a Serious Adverse Event (SAE) from randomization to Week 4.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=118 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=62 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE) or a Serious Adverse Event (SAE) From Randomization to Week 4	0 Participants	6 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to Week 4

The secondary outcome is percentage of participants with an SAE from randomization to Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=118 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=62 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With an Serious Adverse Event (SAE) From Randomization to Week 4	0 Participants	2 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to Week 4

The Secondary Safety Outcome is percentage of participants with symptomatic hypotension from randomization to Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=118 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=62 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Symptomatic Hypotension From Randomization to Week 4	4 Participants	6 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The Secondary safety outcome is percentage of participants with serum sodium concentration below 135 mmol/l at Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 4	4 Participants	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The Secondary safety outcome is percentage of participants with serum sodium concentration above 145 mmol/l at Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 4	4 Participants	5 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The secondary safety outcome is percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
The Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 4	4 Participants	6 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The secondary safety outcome is percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 4.

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 4	1 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Randomization to Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The secondary safety outcome is percentage of participants with eGFR drop of over 30% from randomization to Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With eGFR Drop of Over 30% From Randomization to Week 4	0 Participants	0 Participants	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The secondary safety outcome is percentage of participants with serum sodium \<135mmol/l or \>145 mmol/l, and/or serum potassium \<3.5 mmol/l or \>5.5mmol/l at Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Serum Sodium <135mmol/l or >145 mmol/l, and/or Serum Potassium <3.5 mmol/l or >5.5mmol/l at Week 4	12 Participants	12 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The secondary safety outcome percentage of participants with postural hypotension at Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Postural Hypotension at Week 4	7 Participants	4 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: At Week 4

Population: The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized.

The secondary safety outcome is percentage of participants with postural hypertension at Week 4

Outcome measures

Outcome measures
Measure	Triple ¼ (GMRx2) n=113 Participants Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 Participants Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 Participants Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.
Percentage of Participants With Postural Hypertension at Week 4	19 Participants	31 Participants	13 Participants

Adverse Events

Triple ¼ (GMRx2)

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Triple ½ (GMRx2)

Serious events: 3 serious events

Other events: 32 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Not Randomized

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Triple ¼ (GMRx2) n=113 participants at risk Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg: Oral tablets Over encapsulated Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg oral tablet once daily in the morning after home blood pressure (BP) measurement from week 1 to week 4	Triple ½ (GMRx2) n=119 participants at risk Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg: Oral tablets Over encapsulated Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg oral tablet once daily in the morning after home BP measurement from week 1 to week 4	Placebo n=63 participants at risk Placebo Placebo: Placebo One tablet daily in the morning after home BP measurement from week 1 to week 4.	Not Randomized n=460 participants at risk Participants who were run-in failure and were not randomized
Nervous system disorders Cerebrovascular accident	0.00% 0/113 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.84% 1/119 • Number of events 1 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/63 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/460 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in
Infections and infestations COVID-19	0.00% 0/113 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	1.7% 2/119 • Number of events 2 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	3.2% 2/63 • Number of events 2 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/460 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in
Vascular disorders Arteritis	0.00% 0/113 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/119 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/63 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.22% 1/460 • Number of events 1 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in
Vascular disorders Hypertension	0.00% 0/113 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/119 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.00% 0/63 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in	0.22% 1/460 • Number of events 1 • 6 weeks (Single-blind placebo run-in period of 2 weeks and double-blind period of 4 weeks) The Safety Set is defined as all participants who took at least one dose of study treatment, including during period 1 single-blind placebo run-in

Other adverse events

Additional Information

Anthony Rodgers (Principal Investigator)

George Medicines Pty Limited

Phone: +44 7983 578 290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place