Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2025-12-16 @ 7:49 PM
Study NCT ID:
NCT04518293
Status:
None
Last Update Posted:
2025-06-03 00:00:00
First Post:
2020-08-15 00:00:00
Brief Title:
Efficacy and Safety of GMRx2 Compared to Dual Combinations for the Treatment of Hypertension
Sponsor:
George Medicines PTY Limited
Organization:
George Medicines PTY Limited
Study Overview
Official Title:
Efficacy and Safety of GMRx2 (a Single Pill Combination Containing Telmisartan/Amlodipine/Indapamide) Compared to Dual Combinations for the Treatment of Hypertension
Status:
None
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GMRx2_ACT
Brief Summary:
TRIAL DRUG:
GMRx2: Single pill combinations of telmisartan/amlodipine/indapamide Dose version 2: telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg Dose version 3: telmisartan 40mg/amlodipine 5 mg/indapamide 2.5mg INDICATION: Hypertension TRIAL DESIGN: International, multicenter, randomized, double-blind, active controlled, parallel-group.
OBJECTIVES: To investigate the efficacy and safety of GMRx2 compared to dual combinations
INTERVENTION:
Single-Blind Active Run-In Period. Enrolled participants will be asked to discontinue their current BP-lowering drug(s) and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2. Participants will be advised to take the capsule once daily in the morning at approximately the same time each day. For days on which BP is being measured, the capsule should be taken directly after the morning home BP measurement.
Double-Blind Treatment Period. Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups: GMRx2 dose version 2, or telmisartan 20mg+amlodipine2.5mg, or telmisartan 20mg+indapamide 1.25mg, or amlodipine 2.5mg+indapamide 1.25mg. At week 6 all doses will be doubled.
GMRx2: Single pill combinations of telmisartan/amlodipine/indapamide Dose version 2: telmisartan 20mg/amlodipine 2.5mg/indapamide 1.25mg Dose version 3: telmisartan 40mg/amlodipine 5 mg/indapamide 2.5mg INDICATION: Hypertension TRIAL DESIGN: International, multicenter, randomized, double-blind, active controlled, parallel-group.
OBJECTIVES: To investigate the efficacy and safety of GMRx2 compared to dual combinations
INTERVENTION:
Single-Blind Active Run-In Period. Enrolled participants will be asked to discontinue their current BP-lowering drug(s) and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2. Participants will be advised to take the capsule once daily in the morning at approximately the same time each day. For days on which BP is being measured, the capsule should be taken directly after the morning home BP measurement.
Double-Blind Treatment Period. Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups: GMRx2 dose version 2, or telmisartan 20mg+amlodipine2.5mg, or telmisartan 20mg+indapamide 1.25mg, or amlodipine 2.5mg+indapamide 1.25mg. At week 6 all doses will be doubled.
Detailed Description:
TRIAL DRUG
GMRx2 Single pill combinations of telmisartanamlodipineindapamide Dose version 2 telmisartan 20mgamlodipine 25mgindapamide 125mg Dose version 3 telmisartan 40mgamlodipine 5 mgindapamide 25mg INDICATION Hypertension TRIAL DESIGN International multicenter randomized double-blind active controlled parallel-group
OBJECTIVES To investigate the efficacy and safety of GMRx2 compared to dual combinations
INTERVENTION
Single-Blind Active Run-In Period Enrolled participants will be asked to discontinue their current BP-lowering drugs and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2 Participants will be advised to take the capsule once daily in the morning at the same time 2 hours before home BP measurement is performed
Double-Blind Treatment Period Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups GMRx2 dose version 2 or telmisartan20mgamlodipine25mg or telmisartan 20mgindapamide 125mg or amlodipine25mgindapamide 125mg At week 6 all doses will be doubled
GMRx2 Single pill combinations of telmisartanamlodipineindapamide Dose version 2 telmisartan 20mgamlodipine 25mgindapamide 125mg Dose version 3 telmisartan 40mgamlodipine 5 mgindapamide 25mg INDICATION Hypertension TRIAL DESIGN International multicenter randomized double-blind active controlled parallel-group
OBJECTIVES To investigate the efficacy and safety of GMRx2 compared to dual combinations
INTERVENTION
Single-Blind Active Run-In Period Enrolled participants will be asked to discontinue their current BP-lowering drugs and undergo a single-blind active run-in period for 4 weeks with GMRx2 dose version 2 Participants will be advised to take the capsule once daily in the morning at the same time 2 hours before home BP measurement is performed
Double-Blind Treatment Period Participants still eligible after the run-in period will be allocated in a double-blind fashion to one of the following 4 randomized groups GMRx2 dose version 2 or telmisartan20mgamlodipine25mg or telmisartan 20mgindapamide 125mg or amlodipine25mgindapamide 125mg At week 6 all doses will be doubled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None