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Fipamezole in Neurogenic Orthostatic Hypotension

NCT00758849 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2008-10-01

No results posted yet for this study

Summary

The purpose of this study is to determine whether Fipamezole is effective in the treatment of orthostatic hypotension and related symptoms in multiple system atrophy and Parkinson's disease.

Conditions

Interventions

DRUG

Placebo

One placebo tablet administered tid for 12 days in each of the three crossover treatment blocks, each block separated by 2-days placebo washout

DRUG

Fipamezole

One 30-mg tablet of Fipamezole tid from day 1 to 3; one 60-mg tablet of Fipamezole tid from Day 4 to 6; and one 90-mg tablet of Fipamezole tid from Day 7 to 12 in each of the three crossover treatment blocks, each block separated by 2-days placebo washout

Sponsors & Collaborators

  • Santhera Pharmaceuticals

    collaborator INDUSTRY

  • Juvantia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Olivier Rascol, MD · Hôpital Purpan CIC du CHU de Toulouse

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • France
  • Portugal

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00758849 on ClinicalTrials.gov