E01ATCAL0308: Efficacy and Tolerability Study to Treat Mild and Moderate Anxiety

Sponsor

Ativus Farmaceutica Ltda (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00944268

Collaborator

(none)

124

Enrollment

Location

Arm

Duration (Months)

30.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Anxiety Efficacy Tolerability	Drug: Passiflora, Crataegus e Salix	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

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

Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2009

Anticipated Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liquid and solid	Drug: Passiflora, Crataegus e Salix Comparison of different pharmaceutics forms of drug

Arm

Intervention/Treatment

Experimental: Liquid and solid

Drug: Passiflora, Crataegus e Salix

Comparison of different pharmaceutics forms of drug

Outcome Measures

Primary Outcome Measures

Hamilton Scales [30 days]

Secondary Outcome Measures

Safety evaluation by adverse events relate. [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Faculdade de Medicina do ABC	Santo André	São Paulo	Brazil	09060650

Sponsors and Collaborators

Ativus Farmaceutica Ltda

Investigators

Principal Investigator: Elie Fiss, Faculdade de Medicina do ABC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00944268

Other Study ID Numbers:

E01-AT-CAL-03-08

First Posted:

Jul 23, 2009

Last Update Posted:

Jul 24, 2009

Last Verified:

Jul 1, 2009

Keywords provided by , ,

Passiflora, Crataegus and Salix

Mild and Moderate anxiety

Tablet

To evaluate the efficacy and tolerability of the combination

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Jul 24, 2009