CLINICAL TRIALS
COMPLETED
STUDIES
Asthma:
Protocol No.
P04295: A
placebo-controlled study of the effects of Pleconaril nasal spray on
common cold symptoms and asthma exacerbations following rhinovirus
exposure.
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Atrial
Fibrillation:
Protocol
No. EFC5555: A placebo-controlled,
double-blind, parallel arm trial to assess the efficacy of Dronedarone
400mg bid for the prevention of cardiovascular hospitalization or death
from any cause in patients with atrial fibrillation/flutter (AF/AFL).
Cardiac:
Protocol No. CVAL 489108: Long term safety and efficiency of
Valsartan/Captopril and their combination in high risk patients after MI.
Conjuctivitis
(Pink Eye):
Protocol
No. 434: A study to
evaluate the clinical and microbial efficacy of 0.6% ISV-403 compared to VIgamox
in the treatment of bacterial conjunctivitis.
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Constipation:
May 2004 - December 2004: A randomized, double-blind, placebo-controlled,
multicenter evaluation of efficacy and safety of Tegaserod (6 mg bid)
administered orally for 12 weeks in male patients with constipation.
Diabetes:
Study
1:
Protocol
No. LAF237A23119: A multi-center, randomized, open-label,
active controlled, parallel arm study to compare the efficacy of 12 weeks
of treatment with Vildagliptin 100 mg, qd to Thiazolidinedione (TZD) as
add-on therapy in patients with Type 2 diabetes inadequately controlled
with metformin monotherapy in a community-based practice setting.
Study
2:
Protocol
No. 01-05-TL-322OPI-001: A
multicenter, randomized, double-blind, placebo-controlled study to
determine the efficacy and safety of the combination of SYR-322
(SYR110322) and Pioglitazone HCl (ACTOS®) in subjects with Type 2
diabetes.
Study
3:
Protocol
No. 01-06-TL-322OPI-002: A multicenter, double-blind
study to determine the efficacy and safety of SYR-322 plus Pioglitazone
HCl (Actos®), SYR-322 alone or Pioglitazone HCl alone in subjects with
Type 2 diabetes.
Study
4:
Protocol
No. SYR-322-OLE-012: A long-term, open-label
extension study to investigate the long-term safety of SYR110322
(SYR-322) in subjects with Type 2 diabetes.
Study
5:
Protocol
No. BIAsp 2192: Efficacy and safety of standard titration
algorithm coupled with a conventional dietary intervention or intensive
dietary intervention versus a standard titration algorithm, alone, in
patients with type 2 diabetes initiating Novolog® Mix 70/30 therapy.
Study
6:
Protocol
No. 01-06-TL-SYR472-007: A phase II, double-blind
randomized, placebo-controlled, parallel group, multicenter study to
evaluate treatment with SYR-472 in subjects with Type 2 diabetes.
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Hypertension:
Study 1:
Protocol No. CVEA489A2302: An 8-week, multicenter,
randomized, double-blind, parallel-group study to evaluate the efficacy
and safety of the combination of Valsartan/HCTZ/Amlodipine compared to
Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in patients
with moderate to severe hypertension.
Study
2:
Protocol No. 197: Trial of preventing
hypertension.
Study 3:
Protocol
No. 303: Efficacy of dosing Candesartan + Lisinopril
compared to uptritation of Lisinopril.
Study
4:
Protocol
No. 2201: Double-blind, placebo-controlled, efficacy and
safety of Valsartan and Amilodipine combined and alone in hypertensive
patients.
Study
5:
Protocol No.
CFD105453: A randomized, double-blind, double-dummy, parallel group,
factorial design trial to assess the efficacy and safety of up to six
weeks treatment with 20mg, 40mg, or 80mg QD doses of carvedilol
controlled release formulation (Coreg CR) or 10mg, 20mg, or 40 mg QD
doses of Lisinopril (Zestril) or a combination of one of the doses of
each medication.
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Study 6:
Protocol No. CFD109701: A
study to evaluate the potential incidence of orthostatic hypotension in
elderly hypertensive patients following administration of a combination
of COREG CR and lisinopril.
Osteopenia:
Protocol No. CZOL446N2312: A 2-year, randomized, multicenter, double-blind,
placebo-controlled study to determine the efficacy and safety of
intravenous zoledronic acid 5 mg administered either annually at
randomization and 12 months, or administered at randomization only in the
prevention of bone loss in postmenopausal women with Osteopenia.
Osteoporosis:
Study
1:
Protocol
No. MF4411: lbandronate in research of
Osteoporosis.
Study 2:
Protocol
No. Baycol 003: Cervistatin effects on bone
density & cholesterol.
Study 3:
Protocol
No. ALXI-11-93001: Effect on fracture incident in postmenopausal
women.
Study 4:
Protocol
No. CZOL446H2301: Double-blind,
placebo-controlled study to evaluate efficacy and safety of Zoledronic
Acid in the treatment of Osteoporosis in postmenopausal woman taking
calcium plus vitamin D.
Study 5:
Protocol
No. BM16550: Randomized, double-blind,
parallel groups, multicenter study to compare the efficacy and safety of
two IV lbandronate dose regimens (2mg every 2 months, 3 mg every 3
months) with 2.5 oral Ibandronate in postmenopausal Osteoporosis.
Study 6:
Protocol
No. CLI-11-002: An 18-month open-label
extension study (OLES) of the safety and efficacy of recombinant human
parathyroid hormone (RhPTH(I-84)) ALXL- I 1, in women with postmenopausal
Osteoporosis who participated in Protocol ALXI-L 1-93001.
Study 7:
Protocol
No. CL1-11-008: A study to evaluate the
effects of calcium supplementation on the efficacy and safety of
recombinant human Parathyroid hormone (ALX1 -11) in postmenopausal women
with osteoporosis (CAP Study).
Study 8:
Protocol
No. ML18056: A prospective, open-label,
multicenter, two-part study to investigate patient satisfaction with
monthly dosed ibandronate therapy in women with postmenopausal
Osteoporosis or Osteopenia transitioned from once-weekly Alendronate or
Risedronate.
Study 9:
Protocol No. MM17385: (Non-inferiority trial) Randomized,
double-blind, double-dummy parallel group, multicenter study to compare
the efficacy and safety of once-monthly oral administration of 150 mg
Ibandronate with once-weekly oral administration of 70 mg Alendronate in
postmenopausal osteoporosis.
Study 10:
Protocol
No. AMG16220050234: A randomized study to
evaluate safety and efficacy of transitioning therapy from Alendronate to
Denosumab (AMG 162) in postmenopausal women with low bone mineral
density.
Study 11:
Protocol No. MA17904: Open label, parallel group, multicenter
study of two IV ibandronate regimens (2 mg every 2 months and 3 mg every
3 months) in women with postmenopausal Osteoporosis who completed trial
BM16550.
Respiratory
Illness:
Protocol No. 843-044: A placebo-controlled,
double-blind, randomized trial of a tablet formation of Pleconoril in the
treatment of Viral upper respiratory illness in adults.
Rheumatoid Arthritis:
Study 1:
Protocol No. 190-055: The
effect of Eszopiclone 3 mg compared to placebo on daytime function in
subjects with insomnia related to rheumatoid arthritis.
Study 2:
Protocol No. CRx-102-007: A randomized,
double-blind, placebo-controlled, multi-center study to evaluate the
superiority of CRx-102 over each of its components when given to subject
with active Rheumatoid Arthritis (RA).
Tendonitis/Bursitis:
Protocol
No. EN3269-304: A randomized, double-blind,
placebo-controlled, parallel group phase III study of the efficacy,
tolerability and safety of Ketoprofen Topical Patch (KTP) in the
treatment of pain associated with tendonitis or bursitis of the shoulder,
elbow or knee.
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Last Updated
KLP 9/9/08 |
