CLINICAL TRIALS PROFILE FOR MODURETIC 5-50

All Clinical Trials for MODURETIC 5-50

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02853045 ↗	Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients	Completed	Centre Hospitalier Universitaire de Saint Etienne	Phase 4	2015-06-11	Despite a large diffusion for generic anti-hypertensive, they are not currently used. Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only. A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria. The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.
NCT03031496 ↗	Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions	Completed	GlaxoSmithKline	Phase 1	2017-03-17	The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ) (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and hepatic cirrhosis with ascites and edema. This first time in human (FTIH) study is aimed to determine whether the test product GSK3542503 is bioequivalent to the reference (ref) hydrochlorothiazide 50 milligram (mg)/amiloride hydrochlorothiazide 5 mg in healthy adult participants under fasting conditions based on pharmacokinetic (PK) endpoints. This is a phase I, open label, balanced, randomized, single dose, two-way crossover study, enroling approximately 42 healthy participants at a single center. Study participants will be randomized to one of two treatment sequences (A-B or B-A) in accordance with the randomization schedule. A single dose of one of the two treatments A (Test: GSK3542503, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination) or B (Reference: Moduretic, a hydrochlorothiazide 50 mg and amiloride hydrochloride 5 mg fixed dose combination), will be administered on Day 1, in each treatment period. Each participant will participate in both treatment periods and receive a single dose of each treatment. The treatment periods will be separated by a washout period of at least 7 days and no more than 14 days. The total duration in the study for each participant is expected to be 5 to 7 weeks, from screening to his or her last visit. A maximum of 42 participants will be randomized such that at least 32 evaluable participants complete the study.

Clinical Trial Conditions for MODURETIC 5-50

Condition Name

Condition Name for MODURETIC 5-50
Intervention	Trials
Hypertension	2

Condition MeSH

Condition MeSH for MODURETIC 5-50
Intervention	Trials
Hypertension	2

Clinical Trial Locations for MODURETIC 5-50

Trials by Country

Trials by Country for MODURETIC 5-50
Location	Trials
South Africa	1
France	1

Clinical Trial Progress for MODURETIC 5-50

Clinical Trial Phase

Clinical Trial Phase for MODURETIC 5-50
Clinical Trial Phase	Trials
Phase 4	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for MODURETIC 5-50
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for MODURETIC 5-50

Sponsor Name

Sponsor Name for MODURETIC 5-50
Sponsor	Trials
Centre Hospitalier Universitaire de Saint Etienne	1
GlaxoSmithKline	1

Sponsor Type

Sponsor Type for MODURETIC 5-50
Sponsor	Trials
Other	1
Industry	1