Who is sponsoring NCT00714688?

NCT00714688 is sponsored by Janssen-Cilag International NV.

What drugs are being tested in NCT00714688?

Interventions in NCT00714688: prolonged release (PR) OROS methylphenidate 54 mg, prolonged release (PR) OROS methylphenidate 72 mg, Placebo.

What condition does NCT00714688 study?

NCT00714688 studies Attention Deficit/ Hyperactivity Disorder.

Is NCT00714688 still recruiting?

NCT00714688 is currently completed. Last updated 24 April 2014.

Are results published for NCT00714688?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2014-04-24 · How we verify

NCT00714688

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

A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose-Response Study to Evaluate Efficacy and Safety of Prolonged Release (PR) OROS Methylphenidate (54 and 72 mg/Day) in Adults With Attention Deficit/Hyperactivity Disorder

Completed Phase 3 Results posted Last updated 24 April 2014

What this trial tests

Phase 3 trial testing prolonged release (PR) OROS methylphenidate 54 mg in Attention Deficit/ Hyperactivity Disorder in 279 participants. Completed in 1 April 2009.

Timeline

1 February 2008

Primary endpoint
1 April 2009

1 April 2009

Quick facts

Lead sponsor	Janssen-Cilag International NV
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	279
Start date	1 February 2008
Primary completion	1 April 2009
Estimated completion	1 April 2009
Sites	42 locations across Belgium, Denmark, Finland, France, Germany, Netherlands, Norway, Spain

Drugs / interventions tested

prolonged release (PR) OROS methylphenidate 54 mg — full drug profile →
prolonged release (PR) OROS methylphenidate 72 mg — full drug profile →
Placebo

Conditions studied

Attention Deficit/ Hyperactivity Disorder — all drugs for Attention Deficit/ Hyperactivity Disorder →

Sponsor

Janssen-Cilag International NV — full company profile →

Who can join

Adults 18 to 65, any sex, with Attention Deficit/ Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Attention Deficit/Hyperactivity Disorder (ADHD) Symptoms Total Score of the Conners Adult ADHD Rating Scale (CAARS)
Time frame: from baseline to 13 weeks
The primary endpoint was the change in the ADHD symptoms total score of the investigator-rated CAARS from baseline to the last assessment in the double-blind treatment period. CAARS assesses ADHD symptoms and behaviors in adults using a scale ranging from 0 (best) to 54 (worst). For subjects without a post-baseline efficacy measurement, a change of 0 units was imputed.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of 2 fixed dosages of Prolonged Release (PR) OROS methylphenidate (54 and 72 mg/day) compared with placebo in adult patients with attention deficit/hyperactivity disorder (ADHD).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults.
Boesen K, Paludan-Müller AS, Gøtzsche PC, Jørgensen KJ. · · 2022 · cited 12× · PMID 35201607 · DOI 10.1002/14651858.cd012857.pub2

Verify or expand the search:

Other recruiting trials for Attention Deficit/ Hyperactivity Disorder

Currently open trials in the same condition.

NCT06180681 — Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD · NA · recruiting

Other Janssen-Cilag International NV trials

Trials by the same sponsor.

NCT04940039 — A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings · Phase 4 · completed
NCT04338321 — A Long-term Comparison of Esketamine Nasal Spray Versus Quetiapine Extended Release, Both in Combination With a Selectiv · Phase 3 · completed
NCT03852160 — A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Stan · Phase 3 · withdrawn
NCT03947814 — A Study of Orally Administered Pimodivir in Adult Participants With Renal Impairment · Phase 1 · terminated
NCT03816631 — A Study of Orally Administered Pimodivir in Adult Participants With Hepatic Impairment · Phase 1 · 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 NCT00714688 (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 Janssen-Cilag International NV
Last refreshed: 24 April 2014

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/NCT00714688.

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