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BAY38-9456 - Pivotal Trial for Diabetes Patient

2014-08-27 03:30:37 | BioPortfolio

Summary

The superiority of BAY 38-9456 10 mg and 20 mg regimens to placebo, and of 20 mg to 10 mg was confirmed in patients with diabetes mellitus suffering from erectile dysfunction. There was no large difference in incidence rate of drug-related adverse events between 10 mg and 20 mg regimens. Overall the tolerability was considered good with both regimens.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Erectile Dysfunction

Intervention

Levitra (Vardenafil, BAY38-9456), Levitra (Vardenafil, BAY38-9456), Placebo

Status

Completed

Source

Bayer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:37-0400

Clinical Trials [46 Associated Clinical Trials listed on BioPortfolio]

BAY38-9456 (Vardenafil HCL Tablet) in ED Treatment for China Registration.

This study was to compare the efficacy of 3 doses of vardenafil, 5 mg, 10 mg and 20 mg, with matching placebo in Chinese male ED patients, treated for a maximum of 12 weeks.

Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-Sparing Prostatectomy for Improving ED

A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability ...

Sustainable Efficacy of Vardenafil OD Versus Vardenafil PRN in Erectile Dysfunction

Compare once daily vs on demand treatment in men with erectile dysfunction. Treatment of mild to moderate erectile dysfunction with 10 mg vardenafil p.o. over 24 weeks + 4 weeks wash-out:...

BAY38-9456 - Supportive Trial for Spinal Injury

BAY 38-9456 10 mg and 20 mg can be given as safe and efficacious medications to patients with spinal cord injury suffering from erectile dysfunction, and that erectile dysfunction can be i...

Assessment of Vardenafil in Patients With Erectile Dysfunction in Asia

To demonstrate the efficacy, safety and tolerability of 10 mg oral vardenafil (BAY 38-9456) compared to placebo for a period of 12 weeks in men with erectile dysfunction (ED)

PubMed Articles [6 Associated PubMed Articles listed on BioPortfolio]

Polyamidoamine (PAMAM) dendrimers as potential release modulators and oral bioavailability enhancers of Vardenafil hydrochloride.

Vardenafil hydrochloride (VAR) is an erectile dysfunction treating drug. VAR has a short elimination half-life (4-5 h) and suffers low oral bioavailability (15%). This work aimed to explore the dual...

Lipomers (Lipid-polymer Hybrid Particles) of Vardenafil Hydrochloride: a Promising Dual Platform for Modifying the Drug Release Rate and Enhancing Its Oral Bioavailability.

Vardenafil hydrochloride is commonly used for the curing of erectile dysfunction. VAR suffers certain limitations: (i) short elimination half-life (4-5 h), (ii) low aqueous solubility (0.11 mg/mL), ...

Determination of the illegal adulteration of natural healthcare products with chemical drugs using surface-enhanced Raman scattering.

The illegal adulteration of natural healthcare products with chemical drugs can result in serious health risks for consumers. Thus there is an urgent need for a fast and precise detection method. In t...

Could chronic Vardenafil administration influence the cardiovascular risk in men with type 2 diabetes mellitus?

Appropriate algorithms for the prediction of cardiovascular risk are strongly suggested in clinical practice, although still controversial. In type 2 diabetes mellitus (T2DM), the beneficial effect of...

Sub-efficacious doses of phosphodiesterase 4 and 5 inhibitors improve memory in a mouse model of Alzheimer's disease.

Cyclic nucleotides cAMP and cGMP cooperate to ensure memory acquisition and consolidation. Increasing their levels by phosphodiesterase inhibitors (PDE-Is) enhanced cognitive functions and rescued mem...

Medical and Biotech [MESH] Definitions

A piperazine derivative, PHOSPHODIESTERASE 5 INHIBITOR and VASODILATOR AGENT that is used as a UROLOGICAL AGENT in the treatment of ERECTILE DYSFUNCTION.

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Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


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