TheraRadar
Data updated: May 26, 2026

ALTACE (ramipril)

Cardiovascular Approved 1991-01-28
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
35
Years on Market

Details

Status
Discontinued
First Approved
1991-01-28
Routes
ORAL
Dosage Forms
CAPSULE, TABLET

Companies

KING PHARMS LLC Pfizer
Active Ingredient: RAMIPRIL

ALTACE Approval History

1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
232 FDA actions from 1991 to 2026 · 2 indication expansions
May 2026 SUPPL
Label · Labeling
FDA Letter Label
Apr 2017 SUPPL
Label · Labeling
FDA Letter Label
Sep 2015 SUPPL
Label · Labeling
FDA Letter Label

What ALTACE Treats

4 FDA approvals

Originally approved for its first indication in 1991 . Covers 4 distinct patient populations.

  • Other (4)
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Clinical Trial Registry

40 trials
Trial Sponsor ID Phase Status Title
NCT07547878 RAPID-CKD 026-271 Ph 4 not yet recruiting Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
NCT03475186 results posted IRB00053531 3UG1CA189824-04S1, NCI-2018-01807 Ph 2 completed Testing Ramipril to Prevent Memory Loss in People With Glioblastoma
NCT01037530 results posted 05102009 2009-016600-23 Ph 4 completed Clinical and Cost Effectiveness of ACE Inhibitor, Ramipril, in Intermittent Claudicants
NCT07259512 041/UN27.46/TA.04.19/KEP/EC/20 Ph 4 recruiting Single and Twice-daily Dosing of Ramipril on Renal Function in Chronic Kidney Disease Patients With Reduced Ejection Fraction Heart Failure
NCT02842424 0139-16-ET 00991 Ph 4 recruiting Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
NCT02901977 DoRa 2007-000631-25 Ph 4 completed Doxazosin and Ramipril in Hypertension
NCT00933231 FKC-014 Ph 3 completed Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
NCT05508035 CRACOVIA-HF DW.0701.005.2020P Ph 3 recruiting The Effect of Sacubitril/valsartan Versus Ramipril on Left Ventricular Function and Remodeling in Patients with Ischemic Heart Failure with Mid-range Ejection Fraction
NCT02008786 SAFER-SCAD SAFER-SCAD Ph 4 terminated Statin and Angiotensin-converting Enzyme Inhibitor on Symptoms in Patients With SCAD
NCT02924727 PARADISE-MI results posted CLCZ696G2301 2016-002154-20 Ph 3 completed Prospective ARNI vs ACE Inhibitor Trial to DetermIne Superiority in Reducing Heart Failure Events After MI
NCT03715998 QUORUM results posted QGC001-2QG4 Ph 2 completed Firibastat or Ramipril After Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction
NCT03414723 INT14935 2017-002650-37, U1111-1196-5355 Ph 1 completed A Drug-Drug Interaction Study Between Sotagliflozin and Ramipril
NCT02499822 REVERENT 09F401 Ph 4 completed REducing Blood Pressure Variability in Essential Hypertension With RAmipril vErsus Nifedipine GITS Trial
NCT04582097 PHCL 65 Ph 2, Ph 3 completed Ramipril in Pediatric Patients on Hemodialysis
NCT00980785 SEAIRA results posted 2014-1353 H-2009-0036, A534255 Ph 4 completed Studying the Effects of Antihypertensives on Individuals at Risk for Alzheimer's
NCT02632747 results posted 1245.100 Ph 2 completed Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
NCT01485978 EARLY_PRO-TECT_ALPORT Ph 3 completed Efficacy and Safety Study to Delay Renal Failure in Children With Alport Syndrome
NCT03979976 Ramipril.unifesp Ph 2, Ph 3 completed Ramipril, Endothelial Function and Endothelial Progenitor Cells in Patients With Systemic Lupus Erythematosus
NCT02832973 ResHypOT SaoJoseRPU Ph 4 completed Sequential Nephron Blockade vs. Dual Blockade Renin-angiotensin System + Bisoprolol in Resistant Arterial Hypertension
NCT03770936 liver fibrosis Ph 3 recruiting Effect of Some Drugs on Liver Fibrosis
NCT01234922 results posted IRB00014933 NCI-2010-02043, IRB00014933 Ph 2 terminated Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
NCT02729441 ENDURE 053-2010 Ph 3 completed Perindopril vs Ramipril for Persistence in MAU Reduction Study
NCT00736294 PREFACE 0608066 2006-007032-10 Ph 3 terminated Prevention of Atrial Fibrillation by Inhibition Conversion Enzyme (ICE) After Radiofrequency Ablation of Atrial Flutter
NCT01922141 ASSESS CSPP100A2370 2013-001562-42 Ph 4 withdrawn Aliskiren Study of Safety and Efficacy in Senior Hypertensives
NCT00729365 PREVENTKD results posted 1U01DK071733-01A1 1U01DK071733-01A1 Ph 3 terminated PREVENTKD (Prevent Risks by Early interVEntion at Nighttime in Type 1 Diabetes for Kidney Disease)
NCT01284621 results posted 1245.45 2010-022717-25 Ph 1 completed Relative Bioavailability of Empagliflozin (BI 10773) and Ramipril Administered Together Compared to Empagliflozin (BI 10773) and Ramipril Alone in Healthy Volunteers
NCT00732069 results posted Fibrinolysis in Dialysis R01HL065193-08A2 Ph 2 completed Study of Inflammation and Oxidative Stress in Persons Undergoing Dialysis
NCT01302899 ARIA results posted CSPP100A2260 2009-012196-10 Ph 2 terminated To Study the Effects of Aliskiren on Albuminuria and Various Biomarkers in Patients With Nephropathy
NCT00760214 results posted 01-06-TL-491-020 2007-002583-10, U1111-1113-8982 Ph 3 completed Efficacy and Safety Study of Azilsartan Medoxomil Compared to Ramipril for Treating Essential Hypertension
NCT01703234 GATARAMFGF232012 Ph 4 completed FGF-23 and Endothelial Dysfunction in Diabetic Proteinuric Patients
NCT01005290 results posted P-080646-01 Ph 2 terminated A Pharmacodynamic Study to Evaluate the Effect of a Fixed Dose Combination Pill on Blood Pressure
NCT00923156 ESCAPE-SHF results posted CSPP100A2252 EudraCT 2008-001035-35 Ph 2 completed Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure
NCT01180413 Vasomore 26169 Ph 4 completed Intensive Vasodilator Therapy in Patients With Essential Hypertension
NCT01042392 ALIAS results posted CSPP100AFR01 2009-011296-80 Ph 4 completed Efficacy of Aliskiren Compared to Ramipril in the Treatment of Moderate Systolic Hypertensive Patients
NCT00657865 Ram_Gep_1 2007-007276-41 Ph 4 completed Gene Expression Profiling in Skeletal Muscle of Healthy Subjects Treated With Ramipril
NCT00631917 results posted CSPP100A2404 Ph 4 completed A Study Evaluating the Gastrointestinal (GI) Safety and Tolerability of Aliskiren Compared to Ramipril in Essential Hypertension
NCT00542269 ALTO results posted CSPP100AGB01 Ph 4 terminated Efficacy and Safety of Aliskiren/Ramipril/Amlodipine Compared With Ramipril/Amlodipine and Aliskiren/Amlodipine in Patients With Metabolic Syndrome
NCT00772577 ATTAIN results posted CSPP100AUS07 Ph 4 completed Study of the Efficacy and Safety of Aliskiren HCTZ vs Ramipril in Obese Patients (BMI ≥ 30) With Stage 2 Hypertension
NCT00841880 RAMFE_L_03420 Ph 4 completed China Medical University Hospital (CMUH) Triapin Listing
NCT00893425 GATARAMCD9509 Ph 4 completed Effect of Renin Angiotensin System Blockade on the Fas Antigen (CD95) and Asymmetric Dimethylarginine (ADMA) Levels in Type-2 Diabetic Patients With Proteinuria
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ALTACE FDA Label Details

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Data Sources

FDA Approval: NDA019901 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.