Completed PHASE3 INTERVENTIONAL 4-arm NCT01018511

Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (Neptune)

A Randomized, Double-blind, Parallel Group, Placebo Controlled, Multi-center Study of Fixed Dose Combinations of Solifenacin Succinate (6 mg and 9 mg) With Tamsulosin Hydrochloride OCAS 0.4 mg and Tamsulosin Hydrochloride OCAS 0.4 mg Monotherapy, in Male Subjects With Lower Urinary Tract Symptoms (LUTS) Associated With Benign Prostatic Hyperplasia (BPH) With a Substantial Storage Component

Sponsor: Astellas Pharma Europe B.V.

Conditions Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

Interventions Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg Placebo tamsulosin hydrochloride OCAS 0.4 mg tamsulosin hydrochloride OCAS 0.4 mg tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg) tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)

Updated 9 times since 2017 Last updated: Nov 12, 2024 Started: Jan 11, 2010 Primary completion: Mar 1, 2011 Completion: Mar 1, 2011

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01018511, this PHASE3 trial focuses on Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms and remains completed. Sponsored by Astellas Pharma Europe B.V., it has been updated 9 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Jan 2025 — Sep 2025 [monthly]

Completed PHASE3
Sep 2024 — Jan 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jan 2021 — Dec 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jan 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Astellas Pharma Europe B.V.

Data source: Astellas Pharma Inc

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aix-en-Provence, France , Amsterdam, Netherlands , Angers, France , Antwerp, Belgium , Apeldoorn, Netherlands , Assebroek, Belgium , Avellino, Italy , Bad Ems, Germany , Bari, Italy , Bautzen, Germany and 90 more locations