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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Ativus Farmaceutica Ltda.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944268
First Posted: July 23, 2009
Last Update Posted: July 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ativus Farmaceutica Ltda
July 22, 2009
July 23, 2009
July 24, 2009
September 2009
December 2009   (Final data collection date for primary outcome measure)
Hamilton Scales [ Time Frame: 30 days ]
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 ]
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
Intervention Model: Factorial Assignment
Masking: None (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.
 
Unknown status
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00944268
E01-AT-CAL-03-08
Yes
Not Provided
Not Provided
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