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Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety (E01ATCAL0308)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Ativus Farmaceutica Ltda.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ativus Farmaceutica Ltda
ClinicalTrials.gov Identifier:
NCT00944268
First received: July 22, 2009
Last updated: July 23, 2009
Last verified: July 2009
History of Changes

July 22, 2009
July 23, 2009
September 2009
December 2009   (final data collection date for primary outcome measure)
Hamilton Scales [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00944268 on ClinicalTrials.gov Archive Site
Safety evaluation by adverse events relate. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety
Clinical Study Phase III, Multicenter, Prospective, Open to Evaluate the Efficacy and Tolerability of the Combination Use of Passiflora Incarnata L, Crataegus Oxyacantha and Salix Alba L in Mild and Moderate Anxiety

To evaluate the efficacy and tolerability of the combination use of Passiflora incarnata L, Crataegus oxyacantha and Salix alba L in mild and moderate anxiety.

Clinical study phase III, multicenter, prospective, open.

Patients will be included in sufficient quantity to achieve the minimum number of 124 evaluable patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anxiety
  • Efficacy
  • Tolerability
Drug: Passiflora, Crataegus e Salix
Comparison of different pharmaceutics forms of drug
Experimental: Liquid and solid
Intervention: Drug: Passiflora, Crataegus e Salix
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
124
January 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who achieve scores between 18 and 29 points in the Hamilton Scale for Anxiety;
  • Individuals of any ethnic group male and female, aged above 18 years;
  • Consent of the subject of research (a consent form signed).

Exclusion Criteria:

  • Patients with known hypersensitivity to any components of the formula;
  • Pregnant women and nursing mothers;
  • Patients with endogenous depression, schizophrenia, suicidal tendency;
  • Patients with heart disease unabated, unabated kidney, liver and lung unabated unabated, at the discretion of the investigator;
  • Addiction to drugs, including alcohol, at the discretion of the investigator;
  • Patients who are using any medication that could interfere with the effect of the drug under study;
  • Impossibility of compliance to the protocol
Both
18 Years and older
No
Contact: Dagoberto Brandão 55 11 36733763 dagoberto@phcbrasil.com.br
Brazil
 
NCT00944268
E01-AT-CAL-03-08
Yes
Olinto Mascarenhas Marques, ATIVUS FARMACÊUTICA LTDA
Ativus Farmaceutica Ltda
Not Provided
Principal Investigator: Elie Fiss Faculdade de Medicina do ABC
Ativus Farmaceutica Ltda
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP