NCT04021498 (SIMBA-16) is a Phase 3 clinical trial of Simvastatin 40mg in Pancreatitis Relapsing, sponsored by Enrique de-Madaria.

Who is sponsoring NCT04021498?

NCT04021498 is sponsored by Enrique de-Madaria.

What drugs are being tested in NCT04021498?

Interventions in NCT04021498: Simvastatin 40mg, Placebo.

What condition does NCT04021498 study?

NCT04021498 studies Pancreatitis Relapsing.

Is NCT04021498 still recruiting?

NCT04021498 is currently terminated. Last updated 20 March 2025.

Last reviewed 2025-03-20 · How we verify

NCT04021498: SIMBA-16

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Simvastatin in the Prevention of Recurrent Pancreatitis

Terminated Phase 3 Last updated 20 March 2025

What this trial tests

Phase 3 trial testing Simvastatin 40mg in Pancreatitis Relapsing in 83 participants. Terminated before completion.

Timeline

29 September 2017

Primary endpoint
1 March 2025

1 March 2025

Quick facts

Lead sponsor	Enrique de-Madaria
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	83
Start date	29 September 2017
Primary completion	1 March 2025
Estimated completion	1 March 2025
Sites	1 location across Spain

Drugs / interventions tested

Simvastatin 40mg — full drug profile →
Placebo

Conditions studied

Pancreatitis Relapsing — all drugs for Pancreatitis Relapsing →

Sponsor

Enrique de-Madaria

Who can join

18 and older, any sex, with Pancreatitis Relapsing. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recurrent acute pancreatitis and recurrent relapses of inflammation in chronic pancreatitis are an important problem. In some cases, prevention of these acute flares of inflammation is not possible. Population-based studies and meta-analysis of randomized controlled trials suggest that statins may decrease the incidence of acute pancreatitis. SIMBA aims to investigate the effect of simvastatin on the incidence of new episodes of pancreatitis in recurrent acute pancreatitis and chronic pancreatitis. This is a non-profit, researcher-driven placebo-controlled multicenter (27 Spanish centers) randomized controlled trial

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Simvastatin in the Prevention of Recurrent Pancreatitis: Design and Rationale of a Multicenter Triple-Blind Randomized Controlled Trial, the SIMBA Trial.
Cárdenas-Jaén K, Vaillo-Rocamora A, Gracia Á, Garg PK, et al · · 2020 · cited 8× · PMID 33644082 · DOI 10.3389/fmed.2020.00494
Simvastatin in the prevention of recurrent pancreatitis: a triple-blinded randomised clinical trial (the SIMBA trial).
Guilabert L, Cárdenas-Jaén K, Vaillo-Rocamora A, Ruiz-Rebollo ML, et al · · 2026 · cited 4× · PMID 41482454 · DOI 10.1136/gutjnl-2025-337154

Verify or expand the search:

Other trials of Simvastatin 40mg

Trials testing the same drug.

NCT06379958 — Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects · Phase 1 · recruiting
NCT05586360 — T-reg Function Changes: a Novel Immune Regulatory Effect Underlying Benefit of Statin Use on Lethal Prostate Cancer · Phase 2 · recruiting
NCT04457089 — Statin Therapy to Reduce Progression in Women With Platinum Sensitive Ovarian Cancer · EARLY_PHASE1 · completed
NCT03654053 — Multi-Center Study of the Effects of Simvastatin on Hepatic Decompensation and Death in Subjects Presenting With High-Ri · Phase 3 · active not recruiting
NCT04133792 — Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) · Phase 3 · active not recruiting

Other Enrique de-Madaria trials

Trials by the same sponsor.

NCT05781243 — Normal Saline Versus Lactated Ringer's Solution for Acute Pancreatitis Resuscitation · Phase 4 · completed
NCT04381169 — Aggressive Versus Non-aggressive Goal-directed Fluid Resuscitation in Acute Pancreatitis · Phase 3 · terminated
NCT03650062 — Patient-reported Outcome Scale in Acute Pancreatitis · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04021498 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Enrique de-Madaria
Last refreshed: 20 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04021498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing