Recent Updates
Recently added Catalysts

Ramipril

Phase 3

Glomerulonephritis | Small molecule | Nephrology |Sanofi|Last Updated: Apr 25, 2022

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Ramipril · 3 trials · 4 indications

Phase 3 2Phase 1 1
NCT00437463Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) InhibitorGlomerulonephritis
COMPLETED60 Analytics
NCT00268619FOCUS:Focus On Coronary Unstable SyndromesMyocardial Ischemia
COMPLETED- Analytics
PHASE3COMPLETED
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor
Glomerulonephritis
NCT0043746360
Unlock trial analytics
PHASE3COMPLETED
FOCUS:Focus On Coronary Unstable Syndromes
Myocardial Ischemia
NCT00268619-
Unlock trial analytics

Study Endpoints

Primary Endpoints

Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy)
From the beginning to the end of the study
Development of proteinuria
From the beginning to the end of the study
20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation
From the beginning to the end of the study
body weight, blood pressure, pulse
From the beginning to the end of the study
Adverse effects of treatment
From the beginning to the end of the study
To assess the highly specific C-reactive protein (hsCRP) blood levels
during the study conduct
To assess the tumor necrosing factor alpha (TNFα) blood levels
during the study conduct
Assessment of PK parameter: AUCtau
On Day 10 (Period 2)

Sotagliflozin with ramipril: Area under the curve (AUC) to the end of the dosing period (AUCtau)

Secondary Endpoints

TEAEs collection
From the signature of the informed consent up to the end of the study
Assessment of PK parameter: Cmax
On Day 10 (Period 2)
Assessment of PK parameter: tmax
On Day 10 (Period 2)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRamipril
2NO_INTERVENTION -
SAR439954 with or without ramiprilEXPERIMENTAL* On Period 1, following an overnight fast, subjects will receive once daily single morning oral intake of sotagliflozin from Day 1 to Day 5 followed by the first meal that has to be started within 10 min after dosing. * On Day 1 of the Period 2, study subjects will begin a 10-day ramipril regimen following an overnight fast. From Day 6 to Day 10, subjects will receive once daily single morning oral intake of ramipril concomitantly to the sotagliflozin dosing.

Interventions

NameTypeDescription
RamiprilDRUG2.5mg and increase to 5mg if patient do not develop symptomatic hypotension
Sotagliflozin (SAR439954)DRUGPharmaceutical form: tablets Route of administration: oral
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * biopsy-confirmed IgA nephropathy * proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l Exclusion Criteria: * pregnant or nursing mother, or women of childbearing potential without an effective method of birth control * history of...

Countries:Hong KongGermany
Unlock Eligibility Criteria

Competitive Landscape -Membranoproliferative Glomerulonephritis 2 trials (matched to "Glomerulonephritis")

CompanyTickerTrialsLead PhaseDrugs
Apellis Pharmaceuticals, Inc.APLS2PHASE3Pegcetacoplan
Unlock Competitive Intelligence