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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR FEXOFENADINE HYDROCHLORIDE HIVES

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Clinical Trials for Fexofenadine Hydrochloride Hives

Trial ID Title Status Sponsor Phase Summary
NCT00029692 Effects of Ginseng and Ginkgo on Drug Disposition in Man Completed National Center for Complementary and Integrative Health (NCCIH) Phase 2 This study will assess the effects of ginseng and ginkgo on 1) cognitive function, 2) enzymes that process drugs, and 3) enzymes that may help prevent cancer.
NCT00044811 Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Completed Sanofi Phase 3 The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00044824 Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Completed Sanofi Phase 3 The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
NCT00045955 Long-Term Safety Performance of Fexofenadine in Asthma Completed Sanofi Phase 3 The purpose of this study is to assess the long-term safety performance of fexofenadine compared to montelukast in subjects with asthma
NCT00103012 Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers Completed National Institutes of Health Clinical Center (CC) Phase 4 This study will examine the interaction of the HIV combination medication lopinavir/ritonavir with the herbal products echinacea, ginseng, and ginkgo biloba. Patients with HIV infection often take herbal products and dietary supplements in addition to their doctor-prescribed medicines to treat the disease, lessen the side effects of anti-viral drugs, and improve their overall well being. Alternative medicines such as these may, however, interfere with the elimination of lopinavir/ritonavir from the body, causing either higher or lower blood levels of these drugs than would be expected. This study will assess in healthy subjects any potential harms of taking echinacea, ginseng, or ginkgo biloba together with lopinavir/ritonavir. Healthy normal volunteers between 18 and 50 years of age may be eligible for this study. Candidates are screened with a history, physical examination, and blood tests, including an HIV test and a pregnancy test for women. Pregnant women are excluded from the study. Participants come to the NIH Clinical Center after fasting overnight for the following procedures: Visits 1 and 2: A catheter (plastic tube) is placed in an arm vein to collect blood samples. After the first sample is drawn, the subject takes 8 mg of midazolam syrup and two fexofenadine tablets. Midazolam is a sedative, and fexofenadine (Allegra) is a medicine used to treat allergies. Subjects are given breakfast an hour after taking the drugs. Blood samples are collected at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8 and 24 hours after taking the drugs to measure blood levels of fexofenadine. An extra sample is collected at the 4-hour mark to measure the midazolam level. The catheter is removed after the 8-hour blood draw and subjects are dismissed home. They return the following morning (visit 2) for the 24-hour blood draw. Visit 3: From 7 to 28 days after visit 1, subjects begin taking lopinavir/ritonavir capsules twice a day by mouth for a total of 29.5 days. On day 15 they return to the clinic for lopinavir/ritonavir blood levels as were done for fexofenadine, except that samples are collected once before breakfast and then at 0.5, 1, 2, 3, 4, 6, 8 and 12 hours after the lopinavir/ritonavir dose. An extra sample is collected for routine tests. The catheter is removed after the 12-hour draw and the subject is dismissed home. The next morning, subjects begin taking one of the following: echinacea 500 mg 3 times a day; ginkgo biloba 120 mg twice a day; or ginseng 500 mg 3 times a day for 28 days. Visit 4: On the last day of taking lopinavir/ritonavir, subjects return to the clinic again for blood level measurements of these drugs as on visit 3, except that the catheter is removed and the subject dismissed home after the 8-hour blood draw. Visits 5 and 6: On the last day of taking the herbal supplement, subjects return to the clinic for repeat measurement of fexofenadine and midazolam levels, as described in visits 1 and 2. At the final visit (visit 6) an additional blood sample is collected for repeat laboratory testing.
NCT00261079 Fexofenadine in Pruritic Skin Disease Completed Handok Pharmaceuticals Co., Ltd. Phase 4 Primary objective: - To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin disease Secondary objective: - To evaluate patient's satisfaction of Allegra treatment
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Fexofenadine Hydrochloride Hives

Condition Name

Condition Name for Fexofenadine Hydrochloride Hives
Intervention Trials
Healthy 15
Seasonal Allergic Rhinitis 8
Allergic Rhinitis 6
Asthma 3
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Condition MeSH

Condition MeSH for Fexofenadine Hydrochloride Hives
Intervention Trials
Rhinitis 23
Rhinitis, Allergic 23
Rhinitis, Allergic, Seasonal 13
Pruritus 3
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Clinical Trial Locations for Fexofenadine Hydrochloride Hives

Trials by Country

Trials by Country for Fexofenadine Hydrochloride Hives
Location Trials
United States 41
Switzerland 5
Canada 4
Korea, Republic of 3
Japan 3
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Trials by US State

Trials by US State for Fexofenadine Hydrochloride Hives
Location Trials
New Jersey 10
Texas 3
Maryland 2
Kansas 2
North Dakota 2
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Clinical Trial Progress for Fexofenadine Hydrochloride Hives

Clinical Trial Phase

Clinical Trial Phase for Fexofenadine Hydrochloride Hives
Clinical Trial Phase Trials
Phase 4 25
Phase 3 6
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for Fexofenadine Hydrochloride Hives
Clinical Trial Phase Trials
Completed 49
Recruiting 5
Active, not recruiting 2
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Clinical Trial Sponsors for Fexofenadine Hydrochloride Hives

Sponsor Name

Sponsor Name for Fexofenadine Hydrochloride Hives
Sponsor Trials
Sanofi 14
Merck Sharp & Dohme Corp. 5
Dr. Reddy's Laboratories Limited 5
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Sponsor Type

Sponsor Type for Fexofenadine Hydrochloride Hives
Sponsor Trials
Industry 43
Other 18
NIH 4
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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chubb
Argus Health
Federal Trade Commission
Express Scripts
Boehringer Ingelheim
US Army
Mallinckrodt
Fuji

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