HypertensionPhase 3GMRx2_PCTNCT04518306
Efficacy and Safety of GMRx2 Compared to Placebo for the Treatment of Hypertension
A Phase 3 study testing Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg and Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg in people with Hypertension, run by George Medicines PTY Limited at 47 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg and Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 755 participants
- Where
- 47 sitesin 5 countries
- Study dates
- 14 Jun 2021to 18 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 <10% in the USA.
- Likely diagnosis of hypertension, defined as one or more of:
- automated SBP at this clinic visit according to trial methods (see Appendix 2) of ≥130mmHg on no BP lowering medicines or ≥120mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
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- documentation in last 6 months of office SBP ≥ 140 mmHg and/or DBP ≥ 90mmHg on no BP lowering medicines or SBP ≥ 130 mmHg and/or DBP ≥ 85mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of home SBP ≥ 130 mmHg and/or DBP ≥ 80mmHg on no BP lowering medicines or SBP ≥ 120 mmHg and/or DBP ≥ 75mmHg on 1 BP lowering medicine that will be stopped at this visit, OR
- documentation in last 6 months of ambulatory daytime SBP ≥ 130 mmHg and/or DBP ≥ 80mmHg on no BP lowering medicines or SBP ≥ 120 mmHg and/or DBP ≥ 75mmHg on 1 BP lowering medicine that will be stopped at this visit
- No contraindication to trial medications, including 2-weeks placebo run-in and 4-weeks randomized treatment period with GMRx2 (dose version 1 or 2) or placebo.
- At randomization visit:
- Home seated mean SBP 130-154 mmHg in the week before the randomization visit.
- Adherence of 80-120% to placebo run-in.
- Tolerated placebo run-in.
- Adherence to home BP monitoring schedule: in the week before randomization, at least 6 measures (e.g. ≥2 sets of triplicate 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.
Who cannot join
- At screening visit:
- Receiving 2 or more BP-lowering drugs.
- Clinic seated mean SBP ≥160 mmHg and/or DBP ≥100 mmHg.
- 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 any of the 3 trial medications.
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- 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/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.
- 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 (<20 cm) to allow accurate measurement of BP.
- Currently taking or might need during the trial, a concomitant treatment which is known to interact significantly with the trial medication: 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 (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.
Trial locations and contacts
47 sites in 5 countries.
47 sites in 5 countries
United States23 sites
Meridian Clinical Research
Baton Rouge, Louisiana, 70809
Clinical Research of Brandon
Brandon, Florida, 33511
Inpatient Research Clinic
Hialeah, Florida, 33013
Synergy Groups Medical
Houston, Texas, 77036
Synergy Groups Medical
Houston, Texas, 77087
The University of Tennessee Health Science Center
Memphis, Tennessee, 38105
Suncoast Research Group
Miami, Florida, 33135
New Horizon Research Center
Miami, Florida, 33165
Synergy Groups Medical
Missouri City, Texas, 77459
North Hills Medical Research
North Richland Hills, Texas, 76180
Ocala Research Institute
Ocala, Florida, 34471
Altus Research, Inc
Palm Beach, Florida, 33461
Elite Clinical Studies
Phoenix, Arizona, 85018
Meridian Clinical Research
Portsmouth, Virginia, 23703
Headlands Research
Scottsdale, Arizona, 85260
Buckhead Primary Care Research
Snellville, Georgia, 30078
Valiance Clinical Research
South Gate, California, 90280
Suncoast Research Associates
St. Petersburg, Florida, 33173
Accel Research
St. Petersburg, Florida, 33709
Precision Clinical Research
Sunrise, Florida, 33351
Precision Research Center
Tampa, Florida, 33603
Valiance Clinical Research
Tarzana, California, 91356
Quality of Life Medical & Research Centers, LLC
Tucson, Arizona, 85712
United Kingdom10 sites
Brockwood Medical Practice
Betchworth, Surrey, RH3 7NJ
West Walk Surgery
Bristol, Somerset, BS37 4AX
Lakeside Surgery
Coventry, West Midlands, CV3 6NF
Belmont Health Centre
Harrow, London, HA3 7LT
Burbage Surgery
Hinckley, Leicestershire, LE10 2SE
Newquay Medical
Newquay, Cornwall, TR7 1RU
Abbeywell Surgery
Romsey, SO51 8EN
Steploe Medical Centre
Soham, Cambridgeshire, CB7 5JD
Trowbridge Health Centre
Trowbridge, Wiltshire, BA14 8LW
Albany House Medical Centre
Wellingborough, NN8 4RW
Sri Lanka7 sites
Institute of Cardiology, National Hospital of Sri Lanka
Colombo, 10-01000
Colombo South Teaching Hospital
Dehiwala, 10350
Karapitiya Teaching Hospital
Galle, 80000
Jafna Teaching Hospital
Jaffna, 40000
Kandy National Hospital
Kandy, 20000
Kurunegala Teaching Hospital
Kurunegala, 60000
Colombo North Teaching Hospital
Ragama, 11010
Australia5 sites
Curtin University
Bentley, Western Australia, 6102
Castle Hill Medical Centre
Castle Hill, New South Wales, 2154
Hudson Institute of Medical Research
Clayton, Victoria, 3168
Barwon Health, Geelong University Hospital
Geelong, Victoria, 3220
Royal Perth Hospital
Perth, Western Australia, 6000
Nigeria2 sites
University of Abuja Teaching Hospital
Gwagwalada, Federal Capital Territory, 902101
Aminu Kano Teaching Hospital
Kano
About this study
Official title: Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension
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.
Read the detailed description
TRIAL DRUG:
GMRx2: single pill combination of telmisartan/amlodipine/indapamide Dose version 1: telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Dose version 2: telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg INDICATION: Hypertension
TRIAL TITLE:
Efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension.
OBJECTIVES:
To investigate the efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension.
INTERVENTION:
A 2-week single-blind placebo run-in will be followed by a 4-week double-blind period with randomization to GMRx2 dose version 1, GMRx2 dose version 2 or placebo.
- Conditions
- Hypertension
- Being tested
- Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg, Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mgDrug
Oral tablets
Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mgDrug
Oral tablets
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Triple ¼ (GMRx2) | Experimental | Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Receives: Drug: Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg |
| Triple ½ (GMRx2) | Active comparator | Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg Receives: Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From 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.
Measured: Randomization to Week 4
Secondary outcomes (9)
Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From 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.
Measured: Randomization to Week 4
Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From 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.
Measured: Randomization to Week 4
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4
The percentage of participants achieving averaged clinic SBP <140 and DBP <90 mmHg at Week 4 was evaluated.
Measured: At Week 4
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg 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.
Measured: At Week 4
Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From 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.
Measured: Randomization to Week 4
Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From 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.
Measured: Randomization to Week 4
Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From 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.
Measured: Randomization 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
The percentage of participants achieving home seated mean SBP <135 and DBP <85 mmHg at Week 4 was evaluated
Measured: At Week 4
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4
The percentage of participants achieving averaged home seated mean SBP <130 and DBP <80 mmHg at Week 4 was evaluated
Measured: Randomization to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start14 Jun 2021
- Primary completion19 Sep 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 755 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Medicines PTY Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Rodgers, Professor, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518306
- Sponsor's protocol ID
- GMRx2-HTN-2020-PCT1
- Acronym
- GMRx2_PCT
- Status last verified
- May 2025
- First submitted
- 15 Aug 2020
- Last updated
- 3 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No If the sponsor receives a request for study data, then such requests will be reviewed by sponsor following completion of regulatory submissions and review, and with support from members of the GMRX2 steering committee who will advise on the scientific merit and integrity of the proposed analysis.
Publications
Salam A, de Silva HA, Ojji D, de Silva AP, Galappatthy G, Lakshman P, Kumanan T, Mayurathan G, Pereira T, Rahuman M, Ranasinghe G, Rasnayake L, Uluwattage W, Constantine GR, Kandeepan T, Sani MU, Kumar A, Pant R, Cushman WC, Di Tanna GL, Grobbee D, Narkiewicz K, Oparil S, Poulter NR, Schlaich MP, Schutte AE, Spiering W, Williams B, Wright JT Jr, Gianacas C, Shanthakumar M, Liu X, Freed R, Whelton PK, Rodgers A. Long-Term Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination for the Treatment of Hypertension. Glob Heart. 2025 Oct 31;20(1):102. doi: 10.5334/gh.1481. eCollection 2025.
PubMed 41180852Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee D, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Gutierez A, Sanni A, Lakshman P, McMullen D, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, Whelton P. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. J Am Coll Cardiol. 2024 Dec 10;84(24):2393-2403. doi: 10.1016/j.jacc.2024.08.025. Epub 2024 Aug 31.
PubMed 39217570
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Placebo for the Treatment of Hypertension
- ClinicalTrials.gov ID
- NCT04518306
- Acronym / sponsor ID
- GMRx2_PCT / GMRx2-HTN-2020-PCT1
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants (actual)
- Lead sponsor
- George Medicines PTY LimitedIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Posted 3 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TRIAL DRUG:
GMRx2: single pill combination of telmisartan/amlodipine/indapamide Dose version 1: telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg Dose version 2: telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg INDICATION: Hypertension
TRIAL TITLE:
Efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension.
OBJECTIVES:
To investigate the efficacy and safety of GMRx2 compared to placebo for the treatment of hypertension.
INTERVENTION:
A 2-week single-blind placebo run-in will be followed by a 4-week double-blind period with randomization to GMRx2 dose version 1, GMRx2 dose version 2 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- International, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.
| Arm | Type | Receives |
|---|---|---|
| Triple ¼ (GMRx2) | Experimental | Drug: Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mgTelmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg |
| Triple ½ (GMRx2) | Active comparator | Drug: Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mgTelmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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 <10% in the USA.
- Likely diagnosis of hypertension, defined as one or more of:
- No contraindication to trial medications, including 2-weeks placebo run-in and 4-weeks randomized treatment period with GMRx2 (dose version 1 or 2) or placebo.
Key exclusion criteria (28 listed)
- Receiving 2 or more BP-lowering drugs.
- Clinic seated mean SBP ≥160 mmHg and/or DBP ≥100 mmHg.
- 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 any of the 3 trial medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mgOral tablets | Drug | Triple ¼ (GMRx2) |
| Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mgOral tablets | Drug | Triple ½ (GMRx2) |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4
Time frame: 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.
9 secondary outcomes
Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4
Time frame: Randomization to Week 4
Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4
Time frame: Randomization to Week 4
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4
Time frame: At Week 4
Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4
Time frame: At Week 4
Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4
Time frame: Randomization to Week 4
Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4
Time frame: Randomization to Week 4
Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4
Time frame: Randomization 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
Time frame: At Week 4
Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4
Time frame: Randomization to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41180852Salam A, de Silva HA, Ojji D, de Silva AP, Galappatthy G, Lakshman P, Kumanan T, Mayurathan G, Pereira T, Rahuman M, Ranasinghe G, Rasnayake L, Uluwattage W, Constantine GR, Kandeepan T, Sani MU, Kumar A, Pant R, Cushman WC, Di Tanna GL, Grobbee D, Narkiewicz K, Oparil S, Poulter NR, Schlaich MP, Schutte AE, Spiering W, Williams B, Wright JT Jr, Gianacas C, Shanthakumar M, Liu X, Freed R, Whelton PK, Rodgers A. Long-Term Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination for the Treatment of Hypertension. Glob Heart. 2025 Oct 31;20(1):102. doi: 10.5334/gh.1481. eCollection 2025.
- Derived from this study: PubMed 39217570Rodgers A, Salam A, Schutte AE, Cushman WC, de Silva HA, Di Tanna GL, Grobbee D, Narkiewicz K, Ojji DB, Poulter NR, Schlaich MP, Oparil S, Spiering W, Williams B, Wright JT Jr, Gutierez A, Sanni A, Lakshman P, McMullen D, Ranasinghe G, Gianacas C, Shanthakumar M, Liu X, Wang N, Whelton P. Efficacy and Safety of a Novel Low-Dose Triple Single-Pill Combination Compared With Placebo for Initial Treatment of Hypertension. J Am Coll Cardiol. 2024 Dec 10;84(24):2393-2403. doi: 10.1016/j.jacc.2024.08.025. Epub 2024 Aug 31.
- Individual participant dataSharing planned: No. No If the sponsor receives a request for study data, then such requests will be reviewed by sponsor following completion of regulatory submissions and review, and with support from members of the GMRX2 steering committee who will advise on the scientific merit and integrity of the proposed analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Rodgers, Professor principal investigator
The George Institute
47 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg and Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg in people with Hypertension, run by George Medicines PTY Limited at 47 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, United Kingdom, Sri Lanka, Australia, Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 (time frame: Randomization to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04518306, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.