Clinical Study Results

Results Disclosure For AbbVie (prior sponsor, Abbott) Study Information Formerly On ClinicalStudyResults.org
(Through August 2011)

PhRMA Clinical Study Results Database

In October 2004, PhRMA created the Clinical Study Results Database to improve the transparency of clinical studies on new medicines. Since then, individual company and government databases have expanded dramatically, including the National Library of Medicine's website (www.clinicaltrials.gov). Due to the availability and extensive use of these databases, the PhRMA Clinical Study Results Database was phased out on 20 December 2011.

What did the PhRMA Clinical Study Results Database contain?

The database contained the results from all "hypothesis-testing" clinical studies (mainly Phase III and IV studies) completed since October 1, 2002, for drug products approved in the United States. This included both published articles and unpublished study summaries. This information was presented in a standard format that included the sponsoring company's name, the proprietary and generic names of the drug, a link or reference to the FDA-approved drug label, the studied indication(s), a bibliography of published studies together with a link (where available) to the printed articles, and a summary of the results of clinical studies that have not been published. This summary presentation included information on the drug such as the design of the trial, the number of patients studied, the dose and mode of administration, and a summary of conclusions and outcomes on the safety and efficacy of the drug.

List of products alphabetized by generic name

adalimumab: HUMIRA
cefdinir: Omnicef
clarithromycin: Biaxin
divalproex sodium: Depakote

fenofibrate: TriCor
levosimendan: Simdax
lopinavir/ritonavir: Kaletra
paricalcitol: Zemplar

ritonavir: Norvir
sibutramine: Meridia
trandolapril: Mavik
trandolapril and verapamil: Tarka

Generic Name: adalimumab
Drug Name: HUMIRA

Unique ID	Studied Indications or Disease	Phase	Study Name
M04-691	Crohns Disease	Phase III	Protocol No. M04-691: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the More»
M06-808	Crohns Disease	Phase III	M06-808: A Multicenter, Open-Label Treatment of the Human Anti-TNF Monoclonal Antibody Adalimumab in Patients with Moderate to Severe Crohn's Disease More»
M02-404	Crohns Disease Inflammatory Bowel Disease	Phase III	Protocol No. M02-404: A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monocloncal Antibody Adalimumab for the I More»
M02-403	Inflammatory Bowel Disease Crohns Disease	Phase III	Protocol No. M02-403: A Multicenter, Randomized, Double-blind, Placebo-controlled Study of Human Anti-TNF Monoclonal Antibody Adalimumab for the Induc More»
M05-770	Patient Preference Rheumatoid Arthritis Device	Phase II	Protocol No. M05-770: Trial of Usability in Clinical Settings of the HUMIRA Autoinjector vs. Pre-filled Syringe (TOUCH) Abbott Laboratories (Abbott More»
M04-688	Psoriasis, Moderate-to-Severe	Phase II	Protocol No. M04-688: A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Adalimumab (D2E7) in Jap More»
M02-528	Psoriasis, Plaque	Phase II	Protocol M02-528: A Phase 2, Multicenter Study of the Safety and Efficacy of Adalimumab (D2E7) in Subjects with Moderate to Severe Chronic Plaque Psor More»
M02-529	Psoriasis, Plaque	Phase II	Protocol No. M02-529: A Phase II Multicenter Extension Study of the Safety and Efficacy of Adalimumab (D2E7) in Subjects with Moderate to Severe Chronic Plaque Psoriasis Gordon KB, Langley RG, Leonardi C, et al. Clinical Response to Adalimumab Treatment in Moderate to Severe Psoriasis Patients: Double-Blind, Randomized Clinical Trial and Open-Label Extension Study. J Am Acad Dermatol. Available online at http://www.jaad.org/ More»
M02-538	Psoriasis, Plaque	Phase II	Protocol No. M02-538: Phase 2 Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis. Abbott Labo More»
M03-596	Psoriasis, Plaque	Phase II	Protocol No. M03-596. Phase 2 Extension Study of Two Dosing Schedules of Adalimumab in Subjects with Moderate to Severe Chronic Plaque Psoriasis A More»
M03-656	Psoriasis, Plaque	Phase III	Protocol No. M03-656: A Phase 3, Multicenter Study of the Efficacy and Safety of Long-term Adalimumab Treatment in Subjects with Moderate to Severe C More»
M02-518	Psoriatic Arthritis	Phase III	Protocol No. M02-518: A Phase III Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Subjects More»
M02-537	Psoriatic Arthritis	Phase III	Protocol No. M02-537: A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Ad More»
M02-570	Psoriatic Arthritis	Phase III	Protocol No. M02-570: A Phase III Multicenter Study of the Safety and Efficacy of Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Moderate to More»
W05-399	Psoriatic Arthritis	Phase III	Protocol No. W05-399. A Canadian Open-label Study to Evaluate the Safety and Effectiveness of Adalimumab When Added to Inadequate Therapy for the Tre More»
DE018	Rheumatoid Arthritis	Phase III	Protocol No. DEO18. A Multi-center Open-Label Continuation Study with Subcutaneous D2E7 for Patients with Rheumatoid Arthritis Who Completed a Precedi More»
M02-497	Rheumatoid Arthritis	Phase III	Protocol No. M02-497: An Open-Label, Multi-Center Study to Assess the Safety and Efficacy of the Fully Human Anti-TNF-á Monoclonal Antibody Adalimuma More»
M02-498	Rheumatoid Arthritis	Phase III	Protocol No. M02-498. A Multicenter Study of the Safety of Human Anti-TNF Monoclonal Antibody D2E7 in Subjects with Active Rheumatoid Arthritis Abb More»
M02-527	Rheumatoid Arthritis	Phase III	Protocol No. M02-527: A Multi-centre Randomised, Double-blind Study Comparing Adalimumab (D2E7) Plus MTX With Placebo Plus MTX on Work Disability in S More»
M02-532	Rheumatoid Arthritis	Phase IV	Protocol No. M02-532. An Open-Label Study to Assess the Efficacy and Safety of the Fully Human Anti-TNF-alpha Monoclonal Antibody Adalimumab (D2E7) i More»
M02-556	Rheumatoid Arthritis	Phase III	Protocol No. M02-556: A Randomized, Double-Blind, Placebo-controlled, Phase III Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcut More»
M02-573	Rheumatoid Arthritis	Phase III	Protocol No. M02-573. A Randomized, Double-Blind, Placebo-Controlled, Study of the Human Anti-TNF Antibody Adalimumab Administered as Subcutaneous Inj More»
M02-574	Rheumatoid Arthritis	Phase IV	Protocol No. M02-574. A Multicenter Study of the Safety and Efficacy of Human Anti-TNF Monocloncal Antibody Adalimumab (D2E7) in Patients with Active More»
M02-575	Rheumatoid Arthritis	Phase III	Protocol No. M02-575: A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose-Ranging Study of Subcutaneously Administered A More»
M03-583	Rheumatoid Arthritis	Phase III	Protocol No. M03-583: Multicenter Early Access Program (EAP) of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active R More»
M03-600	Rheumatoid Arthritis	Phase IV	Protocol No. M03-600: Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects with Rheumatoid Arth More»
M04-684	Rheumatoid Arthritis	Phase IV	Protocol No. M04-684: HUMIRA Efficacy Response Optimization Study in Subjects with Active Rheumatoid Arthritis (HERO) Abbott Laboratories (Abbott) More»
M04-716	Rheumatoid Arthritis	Phase III	Protocol No. M04-716. A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Study Comparing the Safety and Efficacy of A More»
M04-724	Rheumatoid Arthritis	Phase III	Protocol No. M04-724. Safety and Efficacy of Adalimumab in Patients with Active Psoriatic Arthritis (PsA) An Open-label, Multinational Study to Eva More»
Mexi‑P01‑03	Rheumatoid Arthritis	Phase III	Protocol No. Mexi-P01-03. Quality of life study with adalimumab in rheumatoid arthritis. ESCALAR. Abbott Laboratories (Abbott) will use reasonable More»
DE038	Rheumatoid Arthritis, Juvenile	Phase III	Protocol No. DE038: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti More»

Generic Name: cefdinir
Drug Name: Omnicef

Unique ID	Studied Indications or Disease	Phase	Study Name
M04-699	Infections, Skin and Skin Structure	Phase IV	Protocol No. M04-699: A Comparative Study of the Safety, Tolerability, and Efficacy of Cefdinir and Cephalexin for the Treatment of Subjects With Mild More»
M03-663	Normal Healthy	Phase I	Protocol No. M03-663: Evaluation of the Effects of Meal Composition and Meal Timing on the Oral Absorption of Cefdinir from a 250 mg/5 mL Cefdinir Ora More»
M01-352	Otitis Media, Acute	Phase III	Protocol No. M01-352: An Open-Label, Safety and Efficacy Study of Cefdinir Oral Suspension, 25 mg/kg Once Daily, in Pediatric Subjects with Acute Otit More»
M02-541	Otitis Media, Acute	Phase IV	Protocol No. M02-541: A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/clavulanate in Pediatric Subjects With Ac More»
M03-630	Otitis Media, Acute	Phase III	Protocol No. M03-630: A Comparison of Safety and Efficacy of Cefdinir Oral Suspension versus Azithromycin in Pediatric Subjects with Acute Otitis Medi More»
M04-701	Otitis Media, Acute	Phase IV	Protocol No. M04-701: A Comparison of the Efficacy and Safety of Cefdinir Oral Suspension vs. High Dose Amoxicillin/Clavulanate in Pediatric Subjects More»
M01-337	Pharmacokinetics	Phase I	Protocol No. M01-337: A Pilot Study of the Assessment of the Pharmacokinetics and Tolerability of An Oral Cefdinir Bowlware K, McCracken G, Lozano- More»
M03-628	Sinusitis	Phase IV	Protocol No. M03-628: A Phase IV Comparative Study of the Safety and Efficacy of Cefdinir and Levofloxacin for the Treatment of Subjects with Acute Ba More»
M02-569	Taste Test	Phase IV	Protocol No. M02-569: A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef versus Amoxicillin Antibiotic Suspension Medications Holas More»
M02-567	Taste Test Patient Preference	Phase IV	Protocol No. M02-567: A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef versus Amoxicillin Antibiotic Suspension Medications Hola More»
M02-568	Taste Test Patient Preference	Phase IV	Protocol No. M02-568: A Comparative, Multi-Center, Pediatric Taste Test Study of Omnicef versus Zithromax Antibiotic Suspension Medications Holas C More»

Generic Name: clarithromycin
Drug Name: Biaxin

Unique ID	Studied Indications or Disease	Phase	Study Name
FRAN‑02‑002	Acute bacterial exacerbations of chronic bronchitis	Phase IV	Protocol No. FRAN-02-002: Efficacy and safety of extended-release clarithromycin (5-day short-course) vs telithromycin, in acute bacterial exacerbation of chronic bronchitis Perronne C, Drugeon H, Zuck P, et al. Efficacy and safety of extended-release clarithromycin (5-day short-course) vs telithromycin, in acute bacterial exacerbation of chronic bronchitis. Available online at http://france.elsevier.com/direct/MEDMAL More»
M02-472	Bronchitis, Chronic	Phase III	Protocol No. M02-472: A Phase III Comparative Efficacy Study of 5 Days of M02-472 Clarithromycin Extended-Release Tablets to 7 Days of Clarithromycin More»
M02-524	Sinusitis	Phase IV	Protocol No. M02-524: A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-release Tablets vs. Amoxicillin-clavulan More»

Generic Name: divalproex sodium
Drug Name: Depakote

Unique ID	Studied Indications or Disease	Phase	Study Name
M01-342	Bipolar Disorder	Phase III	Protocol No. M01-342: A Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Depakote ER for the Treatment of Mania Associat More»
M02-540	Bipolar Disorder	Phase III	Protocol No. M02-540: A 21-Day, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of Depakote ER in the Treatment More»
M02-555	Bipolar I Disorder	Phase III	Protocol No. M02-555: An Open-Label Long-Term Study to Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated More»
M03-647	Bipolar I Disorder	Phase III	Protocol No. M03-647: An Open-Label Study to Evaluate the Safety of Depakote® ER in the Treatment of Mania Associated with Bipolar I Disorder in Child More»
M02-461	Epilepsy (Seizures)	Phase I	Protocol No. M02-461: A 14-Day, Randomized, Open-Label, Cross-Over, Single Center Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs More»
M02-488	Migraine, Prophylaxis	Phase III	Protocol No. M02-488: The Safety and Efficacy of Divalproex Sodium Extended-Release Tablets in Migraine Prophylaxis: A Double-Blind, Placebo-Controlle More»
M02-554	Migraine, Prophylaxis	Phase III	Protocol No. M02-554: The Safety of Divalproex Sodium Extended Release Tablets in Migraine Prophylaxis: An Open-Label Extension Study in Adolescents More»
M03-648	Migraine, Prophylaxis	Phase III	Protocol No. M03-648: Divalproex Sodium Extended-Release Tablets for Migraine Prophylaxis in Adolescents: An Open-Label, Long-Term Safety Study Abb More»
M04-714	Partial Seizures	Phase III	Protocol No. M04-714: An Open-Label Multicenter Study of the Long-Term Safety of Depakote® Sprinkle Capsules in the Treatment of Partial Seizures in C More»
M02-547	Schizophrenia	Phase II	Protocol No. M02-547: A Randomized, Double-Blind Study of the Safety and Efficacy of Depakote ER plus an Atypical Antipsychotic vs. an Atypical Antips More»

Generic Name: fenofibrate
Drug Name: TriCor

Unique ID	Studied Indications or Disease	Phase	Study Name
M03-661	Hyperlipidemia	Phase III	Protocol No. M03-661: A Multicenter, Randomized, Double-Blind, Prospective, Parallel Study to Compare the Safety and Efficacy of Fenofibrate or Ezetim More»
M02-514	Pharmacokinetics	Phase I	Protocol No. M02-514: Effect of Multiple Doses of Fenofibrate on the Multiple-Dose Pharmacokinetics of Pravastatin in Healthy Subjects Gustavson LE More»

Generic Name: levosimendan
Drug Name: Simdax

Unique ID	Studied Indications or Disease	Phase	Study Name
3001077	Acutely decompensated heart failure	Phase III	Protocol No. 3001077: Survival of Patients with Acute Heart Failure in Need of Intravenous Inotropic Support: a Multicentre, Parallel-Group, Randomise More»
3001069	Acutely decompensated heart failure	Phase III	Protocol No. 3001069: Randomized, Multicenter Evaluation of Intravenous LeVosimendan Efficacy Versus Placebo in the Short Term Treatment of Decompens More»

Generic Name: lopinavir/ritonavir
Drug Name: Kaletra

Unique ID	Studied Indications or Disease	Phase	Study Name
FRAN-03-001	HIV Infection	Phase III	Protocol No. FRAN-03-001: A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Vers More»
M00-154	HIV Infection	Phase II	Protocol No. M00-154: A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy with ABT-378/ritonavir (Kaletra®), lamivudine (Epi More»
M01-347	HIV Infection	Phase I	Protocol No. M01-347: Evaluation of Single and Multiple Dose Pharmacokinetics of Lopinavir/Ritonavir in HIV Infected Subjects with Mild and Moderate H More»
M01-384	HIV Infection	Phase II	Protocol No. M01-384. A Phase II Study of Lopinavir/Ritonavir in Combination with Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic To More»
M02-418	HIV Infection	Phase III	Protocol No. M02-418. A Randomized Open-Label Study of 800 mg Lopinavir/200 mg Ritonavir QD in Combination with Tenofovir and Emtricitabine vs. 400 mg More»
M03-613	HIV Infection	Phase II	Protocol No. M03-613: A Randomized, Open-Label Study Assessing Safety, Tolerability, Efficacy, and Metabolic Effects of a Simplified More»
M97-720	HIV Infection	Phase II	Protocol No. M97-720: Phase I/II Study of ABT-378/Ritonavir in Combination with Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected More»
M99-049	HIV Infection	Phase II	Protocol No. M99-049: A Randomized, Open-Label, Phase II Study of High Dose ABT 378/Ritonavir and Standard Dose ABT-378/Ritonavir with Additional Rito More»
PUER‑01‑001	HIV Infection	Phase IV	Protocol No. PUER-01-001: Factors Associated With Adherence in a Cohort of HIV Positive Subjects on a First Time PI Containing HAART Regimen: Observat More»

Generic Name: paricalcitol
Drug Name: Zemplar

Unique ID	Studied Indications or Disease	Phase	Study Name
M01-375	Chronic kidney disease	Phase IV	Protocol No. M01-375: A Phase 4, Double-Blind, Double-Dummy, Single-Center, Randomized, Active- Controlled, Cross-Over, Pilot Study to Evaluate the E More»
2001015	Hyperparathyroidism, Secondary	Phase III	Protocol No. 2001015: A Phase III, Prospective, Placebo-Controlled, Double-Blind, Randomized, Multi-Center Study to Evaluate the Safety and Efficacy o More»
2001019	Hyperparathyroidism, Secondary	Phase III	Protocol No. 2001019: A Phase III, Prospective, Randomized, Placebo-controlled, Double-blind, Multi-center Study to Determine the Safety and Efficacy More»
2001020	Hyperparathyroidism, Secondary	Phase III	Protocol No. 2001020: A Phase III, Prospective, Randomized, Placebo-controlled, Double-blind, Multi-center Study to Determine the Safety and Efficacy More»
2001021	Hyperparathyroidism, Secondary	Phase III	Protocol No. 2001021: A Phase III, Prospective, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Determine the Safety and Efficacy More»
2001022	Hyperparathyroidism, Secondary	Phase IV	Protocol No. 2001022: A Phase 4, Double-Blind, Placebo-Controlled, Multi-Center Study to Determine the Safety and Effectiveness of Zemplar® (Paricalci More»
J‑ZEM‑05‑002	Hyperparathyroidism, Secondary	Phase II	Protocol No. J-ZEM-05-002. A Phase 2, Open-label, Multicenter, Multidose Study to Evaluate the Pharmacokinetics and Tolerability of Paricalcitol Inje More»
M01-367	Hyperparathyroidism, Secondary	Phase IV	Protocol No. M01-367: A Phase IV Randomized, Active-Controlled, Double-Blind, Multi-Center Study to Compare Two Methods of Dosing Zemplar® Injection i More»
M01-395	Hyperparathyroidism, Secondary	Phase II	Protocol No. M01-395: A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Pilot Study to Examine the Safety and Efficacy of Zemplar® to Increase More»
M03-633	Hyperparathyroidism, Secondary	Phase I	Protocol No. M03-633: Phase I, Single and Multiple Dose Study to Determine the Safety, Pharmacokinetics, and Pharmacodynamics of Zemplar Capsule in Su More»
M04-692	Hyperparathyroidism, Secondary	Phase I	Protocol No. M04-692: Effect of Ketoconazole on the Pharmacokinetics of Paricalcitol in Healthy Subjects. Abbott Laboratories (Abbott) will use r More»
M03-635	Hyperparathyroidism, Secondary Chronic kidney disease	Phase III	Protocol No. M03-635: A Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of Zemplar® Cap More»

Generic Name: ritonavir
Drug Name: Norvir

Unique ID	Studied Indications or Disease	Phase	Study Name
M00-261	HIV Infection	Phase II	Protocol No. M00-261: An Open Label, Phase II Study of Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure with Ka More»
M01-287	HIV Infection	Phase II	Protocol No. M01-287: An Open Label, Phase II Study of Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Fail More»

Generic Name: sibutramine
Drug Name: Meridia

Unique ID	Studied Indications or Disease	Phase	Study Name
SB237	Bulimia	Phase III	Protocol No. SB237: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia More»
KD200010	Obesity	Phase IV	Protocol No. 200010: Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination plus Sibutramine versus Placebo in Obese Hypertensive More»
KD20009	Obesity	Phase IV	Protocol No. KD20009: Randomized, Placebo-Controlled Parallel-Group Comparison Evaluating the Effect of Antihypertensive Therapy and Sibutramine on Bl More»
MLAY‑02‑001	Obesity	Phase III	Protocol No. MLAY-02-001. Randomized Trial of Obese Non-Diabetic Malaysians using Sibutramine: A Randomized Double-Blind Placebo-Controlled Study of More»
SB118	Obesity	Phase III	Protocol No. SB118: A Multicenter, Double-blind, Placebo-controlled, Parallel Group Study to Examine the Longer-Term Efficacy and Safety of Meridia (S More»
THAI‑03‑002	Obesity	Phase IV	Protocol No. THAI-03-002: Safety and Weight Reduction in Sibutramine Treatment of Thai Obese and Overweight Subjects More»
SB238	Obesity (Pediatric)	Phase III	Protocol No. SB238: A 12 Month Study to Assess Safety and Efficacy of Meridia (Sibutramine Hydrochloride Monohydrate) 10 and 15 mg in Obese Adolescen More»

Generic Name: trandolapril
Drug Name: Mavik

Unique ID	Studied Indications or Disease	Phase	Study Name
CANA‑03‑003	Hypertension	Phase IV	Protocol No. CANA-03-003: A Prospective, Open-Label Study to Evaluate the Effect of an Escalating Dose Regimen of Trandolapril on Blood Pressure in T More»

Generic Name: trandolapril and verapamil
Drug Name: Tarka

Unique ID	Studied Indications or Disease	Phase	Study Name
M03-598	Hypertension	Phase IV	Protocol No. M03-598: A Phase IV, Randomized, Open-Label, Active controlled Study to Compare the Effects of Tarka and Hyzaar on Glucose Tolerance in S More»
M03-599	Hypertension	Phase IV	Protocol No. M03-599: A Phase 4, Randomized, Open-Label, Active Controlled Study to Compare the Effects of Tarka® and Lotrel® on Albuminuria in Hypert More»