NCT01436253 is a clinical trial of Lifestyle Changes in Dyslipidemia, sponsored by Organon and Co.

Who is sponsoring NCT01436253?

NCT01436253 is sponsored by Organon and Co.

What drugs are being tested in NCT01436253?

Interventions in NCT01436253: Lifestyle Changes, Hypolipemics.

What condition does NCT01436253 study?

NCT01436253 studies Dyslipidemia.

Is NCT01436253 still recruiting?

NCT01436253 is currently completed. Last updated 7 February 2022.

Are results published for NCT01436253?

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

Last reviewed 2022-02-07 · How we verify

NCT01436253

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

Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy

Completed Results posted Last updated 7 February 2022

What this trial tests

trial testing Lifestyle Changes in Dyslipidemia in 2,196 participants. Completed in 1 February 2013.

Timeline

1 December 2008

Primary endpoint
1 February 2013

1 February 2013

Quick facts

Lead sponsor	Organon and Co
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,196
Start date	1 December 2008
Primary completion	1 February 2013
Estimated completion	1 February 2013

Drugs / interventions tested

Lifestyle Changes
Hypolipemics — full drug profile →

Conditions studied

Dyslipidemia — all drugs for Dyslipidemia →

Sponsor

Organon and Co — full company profile →

Who can join

30 and older, any sex, with Dyslipidemia. 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.

Percentage of Participants Achieving Target Lipid Values
Time frame: Baseline and Month 3
Target total cholesterol value was \<4.5 mmol/L and target low densisty lipoprotein (LDL) value was \<2.5 mmol/L
Percentage of Participants With Reduced Cardiovascular Risk
Time frame: Baseline and Month 3
Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occu

Sponsor's own description

This study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lifestyle Changes

Trials testing the same drug.

NCT04193982 — An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vi · Phase 3 · unknown

Other recruiting trials for Dyslipidemia

Currently open trials in the same condition.

NCT07238556 — A Novel Digital Tool Physicians Can Use to Prescribe Exercise to Patients With Cardiovascular Disease Risk Factors · NA · recruiting
NCT07268781 — Impact of Golden Rice-Piper Crocatum Cookies on Lipid Control in Diabetes Mellitus Patients · NA · active not recruiting
NCT06919302 — The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care. · NA · recruiting
NCT07162441 — A Two-arm, Open-label, Single-sequence, Multiple-dose, Cross-over Study to Evaluate the Pharmacokinetic Interaction and · Phase 1 · recruiting
NCT07043166 — Cardiovascular-Kidney-Metabolic Syndrome in Shanghai Zicitizens · recruiting

Other Organon and Co trials

Trials by the same sponsor.

NCT05761444 — Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients · Phase 4 · completed
NCT05789576 — A Study to Investigate Efficacy and Safety of VTAMA® (Tapinarof) Cream, 1% in Plaque Psoriasis in the Head and Neck Regi · Phase 4 · completed
NCT05680740 — A Study to Investigate Efficacy and Safety of VTAMA (Tapinarof) Cream, 1% in Intertriginous Plaque Psoriasis · Phase 4 · completed
NCT05560646 — A Study to Investigate Efficacy and Safety of OG-6219 BID in 3 Dose Levels Compared With Placebo in Participants Aged 18 · Phase 2 · completed
NCT05264506 — Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive · Phase 3 · terminated

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 NCT01436253 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 7 February 2022

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/NCT01436253.

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