Confirmatory Study of the Efficacy and Safety of the Fixed-dose Combination Atorvastatin / Fenofibrate Versus Atorvastatin on the Lipid Profile of Patients With Type 2 Diabetes (T2D) and Dyslipidaemia (DLP).

Phase IIIb, randomized, longitudinal, prospective, multicenter study to evaluate the efficacy and safety of the fixed-dose combination atorvastatin / fenofibrate versus atorvastatin on the lipid profile of patients with type 2 diabetes and dyslipidemia.

Start Date15 Feb 2022

Sponsor / Collaborator

Laboratorios Silanes SA de CV

NCT00664859 / CompletedPhase 2/3

A 12-Month, Open-Label, Extension Study of the Safety and Efficacy of LCP-AtorFen in Subjects With Dyslipidemia

The current study is designed to test the long-term (12-month) safety and efficacy of LCP-AtorFen, a combination of atorvastatin and fenofibrate, in patients with dyslipidemia

Start Date01 Oct 2007

Sponsor / Collaborator

Veloxis Pharmaceuticals A/S

NCT00504829 / CompletedPhase 2

A 12-Week, Multi-Center, Double-Blind, Randomized, Parallel-Group Study, Followed by a 12 Month Extension Study, of the Efficacy and Safety of LCP-AtorFen in Subjects With Dyslipidemia

The current study is designed to test the efficacy, safety and tolerability of LCP-AtorFen, a combination of atorvastatin and fenofibrate.

Start Date01 Jul 2007

Sponsor / Collaborator

Veloxis Pharmaceuticals A/S

100 Clinical Results associated with Atorvastatin Calcium/Fenofibrate

100 Translational Medicine associated with Atorvastatin Calcium/Fenofibrate

100 Patents (Medical) associated with Atorvastatin Calcium/Fenofibrate

News (Medical) associated with Atorvastatin Calcium/Fenofibrate

20 Nov 2007

·www.biospace.com

LifeCycle Pharma Completes Patient Enrollment in Phase II Clinical Trial of LCP-AtorFen for the Treatment of Mixed Dyslipidemia, Initiates 52-Week Open Label Extension Study

H0RSHOLM, Denmark--(BUSINESS WIRE)--LifeCycle Pharma A/S (OMX: LCP) (the “Company” or “LCP”), an emerging specialty pharmaceutical company, today announced that it has completed patient enrollment in its Phase II clinical trial of LCP-AtorFen for the treatment of mixed dyslipidemia, which commenced in July 2007 to compare LCP-AtorFen, the Company’s fixed-dose combination product candidate of atorvastatin and lowest dose fenofibrate, with Lipitor® (40 mg atorvastatin calcium tablets) and Tricor® (145mg fenofibrate tablets). In addition, the Company announced that it has initiated a 52-week, open-label extension study in order to capture additional safety and efficacy data on the use of LCP AtorFen in patients with mixed dyslipidemia.

Collaborate

100 Deals associated with Atorvastatin Calcium/Fenofibrate

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB05769

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dyslipidemias	Phase 3	US	Veloxis Pharmaceuticals A/S	01 Oct 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


23-PUB (ADA2024)	Phase 3	Diabetes Mellitus, Type 2 \| Dyslipidemias	65	Atorvastatin/Fenofibrate 20 mg/160 mg	(ttvyqlrztl) = zjgolucbpw jxifypyxsh (qwzutngswj, 145.3)	Positive	14 Jun 2024
				Atorvastatin 20 mg	(ttvyqlrztl) = rnuxtqnzkh jxifypyxsh (qwzutngswj, 75.7)
NCT00664859 (CTgov)	Phase 2/3	Dyslipidemias	140	LCP-AtorFen (LCP-AtorFen 40/100mg)	dauvipvwnn(ukumicgirw) = cymwijveqx omutsokyye (zdznomyjck, uuxoxougjm - zmtdqprtyi) View more	-	24 Mar 2020
				Atorvastatin (Atorvastatin 40 mg)	dauvipvwnn(ukumicgirw) = tuxpzsqjtv omutsokyye (zdznomyjck, jygimystjp - nmvighblrv) View more
NCT00504829 (CTgov)	Phase 2	Dyslipidemias	220	LCP-AtorFen (LCP-AtorFen 40/100mg)	tfpgbckzaw(fijirmdaxt) = nwtxofcrki nympoucvin (sidhnidhbk, uvgpneyynf - rdgbmphsbd) View more	-	05 Feb 2020
				Atorvastatin (Atorvastatin 40mg)	tfpgbckzaw(fijirmdaxt) = msnrpeycnx nympoucvin (sidhnidhbk, qtjchibzmg - xftviqlpof) View more
NCT01974297 \| NCT00504829 (Pubmed \| Med Lett Drugs Ther)	Phase 2	Dyslipidemias	220	Atorvastatin/fenofibrate FDC	qhrwsmytpo(rgitgypwfy) = wpnlhsqnob xyaczabyoi (jhejbxhozo ) View more	-	01 Dec 2009
				Atorvastatin 40 mg	qhrwsmytpo(rgitgypwfy) = atpqqqeyem xyaczabyoi (jhejbxhozo ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis