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| Sponsor: | Pfizer |
|---|---|
| Information provided by: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00084227 |
Purpose
The primary objective is to confirm the hypothesis that azithromycin plus chloroquine is non-inferior to atovaquone-proguanil for the treatment of symptomatic, uncomplicated malaria due to P. falciparum.
| Condition | Intervention | Phase |
|---|---|---|
|
Malaria, Falciparum |
Drug: Azithromycin/Chloroquine Drug: Atovaquone/Proguanil |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Phase Ii/Iii, Randomized, Double Blind, Comparative Trial Of Azithromycin Plus Chloroquine Versus Atovaquone-Proguanil For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In South America |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
| ClinicalTrials.gov Identifier: | NCT00084227 History of Changes |
| Other Study ID Numbers: | A0661126 |
| Study First Received: | June 9, 2004 |
| Last Updated: | May 10, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Malaria Malaria, Falciparum Protozoan Infections Parasitic Diseases Chloroquine Chloroquine diphosphate Proguanil Atovaquone Malarone Azithromycin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antimalarials Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Filaricides Antinematodal Agents Anthelmintics Central Nervous System Agents Antimetabolites |