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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
ABA-01

A Randomized, Double Blind, Placebo Controlled, Multicentre Trial of Abagovomab Maintenance Therapy in Patients with Epithelial Ovarian Cancer After Complete Response to First Line Chemotherapy

Abagovomab 2 mg/ml subcutaneous
vs
Placebo subcutaneos

Menarini Ricerche S.p.A

Ovarian Cancer
BCBE/05/NEB-PAO/088

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

Nebivolol 5 mg daily or Metoprolol 95 mg daily

Berlin Chemie AG

Hypertension and Peripheral Artery Occlusive Disease (PAOD)
BCBe/04/Neb-Gla/081

Influence of Nebivolol on Ocular perfusion in patients with Glaucoma and arterial
hypertension.

Nebivolol 5 mg vs Bisoprolol 5 mg

Berlin Chemie AG

Hypertension and Glaucoma
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

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) ,or 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 and Metoprolol 50-100 mg

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, HCTZ (hydrochlorothiazide) 25 mg

Berlin Chemie AG

Hypertension And Peripheral Arterial Occlusive Disease (PAOD)
BCBe/04/Neb-Car/082

Comparison of the effects of combined rate and rhythm-control treatment with Nebivolol and electric cardioversion to rate- control treatment with Nebivolol alone on clinical and echocardiographic parameters in patients with Left ventricular dysfunction induced by tachycardia

Nebivolol 5 mg/ die

Berlin Chemie AG

Hypertension and Arrhythmia
OLM/CLIN/I-12/03

Efficacy and Safety of Olmesartan in elderly patients with mild to moderate hypertension

Olmesartan 10/20/40 mg/die vs Ramipril 2,5/5/10 mg/die for 12 weeks; 36 weeks more for patient on Olmesartan 40 mg/die

Malesci Istituto Farmacologico S.p.A/Laboratori Guidotti S.p.A

Hypertension
MeTK/CLIN/NEB/ HYPERTROPHY/03/001

Effects of Nebivolol and Ramipril on Left Ventricular Hypertrophy, Quality of Life and Blood Pressure in patients with mild to moderate hypertension associated to Left Ventricular Hypertropy

Nebivolol 5 mg/ die;
Ramipril 5mg/die

I.E Ulagay Ilac Sanayii Turk AS

Hypertension Left ventricular Hypertrophy
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
MeBN/02/Neb-DHF/001

Effects of The Long-Term Administration Of Nebivolol on the Clinical Symptoms, Exercise Capacity And Left Ventricular Function Of Patients With Diastolic Dysfunction (ELANDD)

Nebivolol,
5-10 mg,
tablets

Menarini Benelux SA/NV

Heart Failure
MeBN/02/Neb-PCI/002

Nebivolol inhibition of coronary artery Smooth muscle cell proliferation after Coronary artery InterventiOn (NESCIO)

Nebivolol,
5 mg,
tablets

Menarini Benelux SA/NV

Angina pectoris post Acute Myocardial Infarction
MeRo/04/Neb-LVD/001

Effects of Nebivolol on Subclinical left ventricular dysfunction. A comparative study against Metoprolol. (ENESYS)

Nebivolol,
5 mg,
tablets, qd
vs.
Metoprolol
50 mg, bid

Berlin-Chemie AG

Hypertension and Left Ventricular Dysfunction
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
LUMI/06/FRO-MIG/002

Frovatriptan Versus Zolmitriptan in the Treatment of Migraine with or without Aura: a Patient Preference Study

Frovatriptan 2.5 mg
Vs
Zolmitriptan 2.5 mg

Istituto Lusofarmaco d’Italia S.p.A.

Migraine
LUMI/06/FRO-MIG/001

A patient preference study of frovatripitan versus rizatriptan for the acute treatment of migraine

Frovatriptan 2.5 mg
Vs
Rizatriptan 10 mg

Istituto Lusofarmaco d’Italia S.p.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

Menarini International Operations Luxemburg S.A.

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