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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
  Purpose

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.


Condition Intervention Phase
Anxiety Efficacy Tolerability Drug: Passiflora, Crataegus e Salix Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ativus Farmaceutica Ltda:

Primary Outcome Measures:
  • Hamilton Scales [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Safety evaluation by adverse events relate. [ Time Frame: 30 days ]

Estimated Enrollment: 124
Study Start Date: September 2009
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liquid and solid Drug: Passiflora, Crataegus e Salix
Comparison of different pharmaceutics forms of drug

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944268


Contacts
Contact: Dagoberto Brandão 55 11 36733763 dagoberto@phcbrasil.com.br

Locations
Brazil
Faculdade de Medicina do ABC Not yet recruiting
Santo André, São Paulo, Brazil, 09060650
Contact: Elie Fiss    55 1149935469    eliefiss@uol.com.br   
Principal Investigator: Elie Fiss         
Sponsors and Collaborators
Ativus Farmaceutica Ltda
Investigators
Principal Investigator: Elie Fiss Faculdade de Medicina do ABC
  More Information

Responsible Party: Olinto Mascarenhas Marques, ATIVUS FARMACÊUTICA LTDA
ClinicalTrials.gov Identifier: NCT00944268     History of Changes
Other Study ID Numbers: E01-AT-CAL-03-08
First Submitted: July 22, 2009
First Posted: July 23, 2009
Last Update Posted: July 24, 2009
Last Verified: July 2009

Keywords provided by Ativus Farmaceutica Ltda:
Passiflora, Crataegus and Salix
Mild and Moderate anxiety
Tablet
To evaluate the efficacy and tolerability of the combination

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders