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Clinical studies
Clinical trial registry

Code Title Intervention Sponsor Therapeutic
Indication
OLMITIAZ-02

Phase III Study Evaluating the Efficacy and Safety of Olmesartan Medoxomil/Hydrochlorothiazide 40/12.5 mg Combination Therapy Versus Olmesartan Medoxomil 40 mg Monotherapy in Patients With Essential Hypertension

Olmesartan Medoxomil Hydrochlorothiazide
40/12.5 mg
Vs
Olmesartan Medoxomil
40 mg.

Menarini Ricerche S.p.A

Essential hypertension
BCBE/05/NEB-PAO/088

Nebivolol vs Metoprolol in Hypertensive Patients with Peripheral Artery Occlusive Disease (PAOD)

Nebivolol
5 mg o.d
vs
Metoprolol
95 mg o.d.

Berlin Chemie AG

Hypertension and Peripheral Artery Occlusive Disease (PAOD)
Guid/05Met-GDM/001

Assessment of effects of a 12-month treatment with Metformin on Insulin action and secretion in women with prior gestational diabetes mellitus (GDM)

Metformin
850 mg
vs
Placebo

Laboratori Guidotti

Diabetes Mellitus
MeFI/04/OBR-IBS/001

Otilonium Bromide in Irritable Bowel Syndrome (OBIS). Double blind, randomized, parallel group, placebo-controlled study to evaluate the effect of otilonium bromide on abdominal pain and quality of life in patients with irritable bowel syndrome

Otilonium bromide
40 mg tablets t.i.d before meals (120 mg OB7day)
Vs
machthing Placebo

A.Menarini Farmaceutica Internazionale srl

Irritable Bowel Sindrome
MeES/05/NeB-EnD/001

Comparison the effects of Nebivolol versus Metoprolol succinate on endothelial function and large artery Stiffness

Nebivolol
5 mg o.d.
Vs
Metoprolol
50-100 mg o.d.

OU Berlin Chemie Menarini Eesti

Hypertension
BCBe/04/Neb-PAO/087

Effects of Nebivolol on the walking distance in patients with essential hypertension and peripheral arterial occlusive disease (PAOD) Fontaine's stage II-A randomized, double blind, multicenter, active substance controlled clinical trial phase III

Nebivolol
5 mg o.d.
Vs
HCTZ (hydrochlorothiazide)
25 mg o.d.

Berlin Chemie AG

Hypertension And Peripheral Arterial Occlusive Disease (PAOD)
GUID/02/Glm-Dia/001

Comparative study on the efficacy and tolerability of a new combination og Glibenclamide (2,5 mg)+ Metformin (850mg) vs a standard combination of Glibenclamide (2,5 mg) + Metformin (400mg), vs monotherapy with Glibenclamide (5 mg) and vs monotherapy with Metformin (850mg), in the treatment of type 2 diabetes mellitus.

Glibenclamide ( 2,5 mg) + Metformin ( 850 mg)
Vs
Glibenclamide (2,5 mg) + Metformin (400 mg)
Vs
Glibenclamide (5mg)
Vs
Metformin (850 mg)

Laboratori Guidotti S.p.A

Diabetes Mellitus
MeBN/02/Zof-AMI/001(ZAAMIS)

A multicenter, double-blind, randomized 2x2 factorial design study to compare the efficacy of early (< 6 hours) versus late (24-48 hours) ACE inhibition and to compare the efficacy of Zofenopril and Lisinopril on oxidative reperfusion injury after a first acute anterior myocardial infarction: ZAAMIS (Zofenopril After Acute Myocardial Infarction Study)

Zofenopril
30 mg twice daily

Menarini Benelux SA/NV

Acute Myocardial Infartcion
MEN/03/ZOF-CHF/001

Comparison between zofenopril and ramipril in combination with ASA on the extent of cardiovascular risk in patients with systolic left ventricular dysfunction after acute myocardial infarction. (SMILE IV trial)

Zofenopril
30 mg bid + ASA
vs.
Ramipril
5 mg bid + ASA

Menarini International Operations Luxemburg S.A., Laboratori Guidotti S.p.A. and Istituto Lusofarmaco d' Italia S.p.A.

Heart Failure Post Acute Myocardial Infarction
MeIn/03/Olm-Hyp/001

Efficacy and safety of Olmesartan medoxomil in elderly patients with mild to moderate hypertension. Randomised, double blind, active-control study in two parallel groups of patients with mild to moderate hypertension

Olmesartan
10-40 mg, qd
vs.
Ramipril
2.5-10 mg, qd

Menarini International Operations Luxemburg S.A.

Hypertension
IC01/03/DKP

Multicentre clinical trial to evaluate the analgesic efficacy and safety of Dexketoprofen (50 mg t.i.d.) vs. Ketorolac (30 mg t.i.d.) by intravenous route as part of balanced analgesic therapy with morphine followed by oral dose administration in postoperative pain

Dexketoprofen
Vs
Ketorolac

Laboratorios Menarini SA

Post surgical Pain
IC01/04/DKP

Multicentre clinical trial to evaluate the analgesic efficacy and safety of Dexketoprofen (50 mg iv single dose, followed by oral dose of 25 mg t.i.d.) vs. Metamizol (2 g iv single dose, and 575 mg t.i.d oral) for the treatment of pain subsequent to ambulatory surgery

Dexketoprofen
Vs
Metamizol

Laboratorios Menarini SA

Post surgical Pain
MEFI/05/DEX-MIG/01

Dexketoprofen Trometamol in the therapy of migraine

Dexketoprofen
25 mg
Vs
Dexketoprofen
50 mg
Vs
Placebo

A Menarini IFR

Migraine
MEIN/06/FRO-PP/002

A double-blind, cross-over patient preference study of frovatriptan versus rizatriptan for the acute treatment of migraine

Frovatriptan 2.5 mg
Vs
Rizatriptan 10 mg

Menarini International Operations Luxemburg S.A

Migraine
MEIN/06/FRO-PP/001

A Double-Blind, Cross-Over Patient Preference Study of Frovatriptan Versus Zolmitriptan for the Acute Treatment of Migraine

Frovatriptan 2.5 mg
Vs
Zolmitriptan 2.5 mg

Menarini International Operations Luxemburg S.A

Migraine
GUI/06/FRO-PP/002

A double-blind, cross-over patient preference study of frovatriptan versus almotriptan for the acute treatment of migraine

Frovatriptan 2.5 mg
Vs
Almotriptan 12.5 mg

Laboratori Guidotti S.p.A.

Migraine
MEFR/05/KET-RHU/001

A phase IV ramdomised, double-blind, double-dummy study in two parallel groups: KETUM 2.5 gel versus Diclofenac 50 mg per os in symtomatic osteoarthritis of the hand

Ketoprofen
2.5% gel t.i.d.
Vs
Dicloflenac
150 mg o.d.

Menarini France S.A.

Osteoarthritis of the hand
MEIN/06/OB-20/80/001

A dose-ranging study of otilonium bromide in patients with irritable bowel syndrome

Otilonium Bromide 20 or 40 or 80 mg t.i.d.
vs
placebo

A. Menarini Industrie Farmaceutiche Riunite

Irritable bowel syndrome
MEES/07/NEB-CBP/001

Effects of Nebivolol and Atenolol on Central Aortic Pressure in Hypertensive Patients (NEPAC)

Nebivolol 5 mg o.d.
vs
Atenolol 50 mg or 100 mg o.d.

Menarini International Operations Luxemburg S.A.

Hypertension
BCBE/07/NEB-SPACE/102

Effects of Nebivolol on the cardiovascular functions, thermoregulation and blood flow during real and simulated conditions of microgravity. MISSION Medicine in Space Study - Investigation on Nebivolol.

Nebivolol 5 mg o.d.
vs
placebo

Berlin –Chemie A.G.

Microgravity cardiovascular dysfunctions
NAK-03 (IRIS)

Double-blind, randomised, placebo-controlled, parallel group study to evaluate the effect of a 4-week treatment with oral doses of men15596 in irritable bowel syndrome

Ibodutant oral tablet

Laboratorios Menarini S.A.-Menarini Group