Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia

... weeks. The primary endpoint of this study was the change in total PANSS score from baseline to endpoint. ... risk of INVEGA((R)) SUSTENNA(TM) is that it may change your heart rhythm. This effect is potentially ... doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations). ...

R788 in TASKi3 Clinical Trial Does Not Meet Efficacy Endpoints in RA Patients Who Had Previously Failed Biologic Therapies - Results Incongruent

... trial. MRI Results TASKi3 Mean change from Baseline in RAMRIS* Scores at Month 3 ... ------ ------ change from Baseline to Month 3 (LOCF) ... activity, patient reported pain score, and any change in CRP in the patient's blood. The primary ...

Results From Trials of DHA in Alzheimer's Disease and Age-Related Cognitive Decline

... the trial. Co-primary outcomes were rate of change on the Alzheimer's disease assessment scale-cognitive (ADAS-cog) and rate of change on Clinical Dementia Scale-sum of the boxes ... However, DHA treatment did not slow the rate of change on tests of mental function (ADAS-cog), global ...

Rigel's R788 Significantly Improves Rheumatoid Arthritis in Phase 2b Clinical Trial

... 123/76 125/77 125/78 change from Baseline to Month 6 (LOCF) ... 136 128 138 Mean change -4 -20 ... activity, patient reported pain score, and any change in C-reactive protein (CRP) in the patients' ...

New Studies Presented at European Society of Anaesthesia Further Validate Masimo PVI(TM) for Noninvasive and Continuous Fluid Monitoring

... non-invasively using the PVI."(1) The change of Upper Limbs PVI in Spinal Block (Comparison in ... block group--PVI of the upper limbs did not change significantly. Researchers summarized that high ... 45): 3AP5-9 2. K. Takeyama, M. Yoshikawa. The change of upper limbs PVI in spinal block (The ...

Merz Pharmaceuticals Announce Three Studies of NT-201 - (Botulinum neurotoxin type A Free From Complexing Proteins)

... up to 20 weeks or until the next injection. The change from Baseline to week 4 for the TWSTRS scores was ... U NT 201 (N= 47), and 240U NT 201 (N= 50). The change in total TWSTRS from baseline to week 4 was -2.4 ... up to 20 weeks or until the next injection. The change from Baseline to week 4 for the TWSTRS scores was ...

Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride: Oral 162

... 33 33 33 change in A1C% from baseline -1.1 -0.9 -0.6 change in A1C% from baseline (in patients ... 58 53 37 change FPG (Fasting Plasma Glucose) mg/dL from ...

Studies Show AFRESA(R) Controls Post-Meal Sugar Levels With Less Weight Gain and Hypoglycemia Risk for Diabetes Patients

... (n=343). The primary endpoint was mean change from baseline to week 52 in A1C. Secondary ... between treatments (22% vs 27%). One-hour PPG change from baseline after a meal challenge was ... (LAA). Pre-specified efficacy endpoints included change in A1C, 1-hour PPG, 2-hour PPG and FPG following ...

AFRESA(R) Phase 3 Pulmonary Function Safety Data in Patients with Diabetes Presented at ADA

... a two-year period showed no difference in mean change in forced expiratory volume in one second ... subjects (n=145). The main study end-point was change from baseline in pre-bronchodilator FEV(1) at 2 ... of 50 ml/year). Secondary endpoints included change from baseline in other PFT parameters (forced ...

Dainippon Sumitomo Pharma Announces Lurasidone Phase III Data in Patients With Schizophrenia

... effect on weight was similar to placebo (median change 0.3 kg for overall lurasidone group vs. 0 kg for ... arms. The pre-specified primary endpoint was change from baseline in the PANSS total score over the ... vs. placebo. A key secondary endpoint was the change from baseline in CGI-S over the six-week study ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... of pirfenidone. The primary endpoint of change in percent predicted Forced Vital Capacity (FVC) ... progression-free survival (PFS) and categorical change in FVC were also met with statistical ... meaningful effect on both the primary endpoint of change in percent predicted FVC and secondary endpoints ...

New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure

... was resumed. The primary endpoint was change in mean SBP from baseline after 12 weeks of ... a 24-hour ABPM. The secondary endpoints included change from baseline in mean 24-hour ambulatory DBP, change from baseline in mean SeSBP and SeDBP and ...

New Data Shows AZOR(R) (amlodipine and olmesartan medoxomil) Significantly Improves 24-Hour Ambulatory Blood Pressure

... not mutually exclusive). The primary endpoint was change in mean systolic blood pressure (SBP) from ... by 24-hour ABPM. Secondary endpoints included change from baseline in mean 24-hour DBP as measured by ABPM; change from baseline in mean daytime, nighttime, and ...

New Studies on Once-Daily Extended Release Pramipexole Presented at American Academy of Neurology Annual Meeting

... analysis. In these patients, the adjusted mean change in the Unified Parkinson's Disease Rating Scale ... extended release group, the adjusted mean change from baseline in the UPDRS II+III score was -11.5 ... of 0 percent. For the placebo group, the mean change was -2.7 points at week 33 versus -4.2 points at ...

Neurocrine Announces Top-Line Results From 702 Study (Lilac PETAL Study) of Elagolix for Treatment of Endometriosis Pain

... consisting of the Patient Global Impression of change (PGIC), an assessment of the changes in ... Efficacy Endpoints: Mean change From Baseline to Week 12 Placebo ... 12 Patient Global Impression of change (mean score, 1-7) 3.2 ...

Oh, My Aching Back: Give Me a Shot of Ozone

... rating the disabling effects of back pain, was a change of 3.9 (with 0 being no pain and 10 representing ... the improvement in pain and function is a real change that can be felt by the patient. Much research in ... 1 psi (pounds per square inch). Thus a very small change in volume creates a ...

Nektar Announces Positive Results from Phase 2 Study of Oral NKTR-118 in Patients with Opioid-Induced Constipation (OIC)

... was no reversal of analgesia as measured by a change in pain Numerical Rating Scale (NRS) and no ... The primary endpoint of the study was a change in SBMs from a two-week baseline period during ... constipation in the absence of laxatives, to the change in SBMs at the end of the first week of ...

Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial

... following first morning dose of levodopa, mean change from baseline in the Unified Parkinson's Disease ... III (motor) score during "ON" time and mean change in Clinical Global Impression of severity of ... in clinical trials. The CGI-C scale measures the change in the patient's clinical status from baseline. ...

Duska Therapeutics Completes Corporate Name Change to Cordex Pharma

... today that it has completed a corporate name change to Cordex Pharma, Inc. As a result of the name ... are pleased to have completed our corporate name change and selected a new ticker symbol. The Cordex name ... medical needs." In addition to the name change and new ticker symbol, Cordex announced several ...

Study Suggests Treatment with Paliperidone ER Significantly Improves Symptoms of Schizoaffective Disorder

... based on the primary outcome parameter of total change in mean PANSS(b) scores, compared to patients on ... on the PANSS and a Clinical Global Impressions of change for Schizoaffective Disorder (CGI-C- SCA)(d) of ... NMS. One risk of paliperidone is that it may change your heart rhythm. This effect is potentially ...

Study Found That Long Term Use of Advair Diskus(R) 250/50 Did Not Adversely Affect Bone Loss in Patients with COPD

... this study, designed to show equivalent rate of change in BMD for Advair and salmeterol, results for ... meet clinical equivalence although the rate of change favored Advair. The data was presented in ... was designed to show equivalence in the rate of change of BMD at the L1-L4 lumbar spine and total hip ...

FDA Approves Rapid-Acting Insulin Apidra(R) for Treatment of Children with Diabetes

... of Apidra(R) to insulin lispro in terms of change in glycohemoglobin (HBA1c), which is the amount of sugar bound to hemoglobin in the blood. The change in HBA1c from baseline to endpoint for Apidra(R) and insulin lispro were similar. The mean HBA1c change in the Apidra(R) population was +0.10% (+ or - ...

CIMZIA(R) (Certolizumab Pegol) Provides Rapid and Sustained Relief from Signs and Symptoms of Rheumatoid Arthritis for Two Years

... (ACR) 20 response(a) scores at Week 24 and change from baseline in modified Total Sharp Scores at ... ACR20 response rate(a) at week 24 and the change from baseline in mTSS(b) at week 52. An ... narrowing measured by X-ray. A smaller change in mTSS reflects less progression of joint ....

New Analyses Indicate that Divigel(R) (estradiol gel) 0.1% Is a Valuable Option for Certain Postmenopausal Women With Hot Flashes

... 0.5 g/day, 0.25 g/day) compared to placebo on the change from baseline to week 12 in the frequency and ... 0.25 g/day) combined compared to placebo on the change from baseline to week 12 in frequency ... 0.25 g/day) combined compared to placebo on the change from baseline to week 12 in the frequency and ...

Novo Nordisk New Data From a Phase 3 Study Confirms Clinical Benefits of Once-Daily Liraglutide in the Management of Type 2 Diabetes

... N=178 N=177 Final HbA1c, % change HbA1c from 7.0 7.1 ... 36* 37* 14 Mean change in weight from baseline, kg -1.02* -2.02 0.60 Mean change in FPG from baseline, mmol/L ...

Neurocrine Biosciences Announces Successful Elagolix PETAL Study in Endometriosis

... endpoint for the PETAL study was the percent change from baseline in mean bone mineral density (BMD) ... to elagolix 150 mg once daily, the mean percent change from baseline at Month 6 was -0.11% for the spine ... the femur (lower bound -0.96%). The mean percent change from baseline at Month 6 for the elagolix 75 ...

Bronchitol Cystic Fibrosis Dose Trial Results Positive

... partners None Primary end points: change in FEV1 8.6% increase (139 mls) on 400 ... 3.7% on 120 mg change in FVC 7.9% increase in FVC on 400 mg ... mg (vs -0.3% on 40 measures; mg, change did not reach significance) CF Questionnaire ...

Amicus Therapeutics Announces Second Quarter 2008 Financial Results

... (59) (179) (129) (1,559) change in fair value of warrant liability ... per share amounts) change in Fair Value ... (86) change in fair value of warrant liability ...

Diverse Approaches to Alzheimer's Therapies Continue to Show Progress at ICAD

... of cognition and the clinician's observation of change (a seven point scale from "markedly improved"=+3 ... at nine months. The average change in ADAS-Cog score at nine months favored IVIg ... of study participants. The antibody produced no change in cognitive scores or in the total amount of ...

New Data Highlight Positive Results of Namenda(R) (memantine HCl) Once-Daily Extended-Release Formulation

... or placebo. The primary endpoints evaluated were change from baseline on the Severe Impairment Battery ... and the Clinician's Interview-Based Impression of change Plus Caregiver Input (CIBIC-Plus) rating at week ... endpoints. Assessments were conducted to evaluate change in behavior from baseline using the ...

Four Alzheimer's Clinical Trials Address a Variety of Treatment Targets - Amyloid, Tau, Synapse Formation

... symptoms for perhaps a year or two, they do not change the underlying course of the disease. It is ... beyond improving symptoms to drugs that actually change the course of the disease. Delaying the onset of ... (2) using memory and thinking tests to assess any change in the participants' mental capacity. ...

Two New Alzheimer's Disease Studies Show Advances Against Different Treatment Targets

... 12, and 16 weeks. The primary endpoint is a change from baseline at Week 12 in a composite score ... efficacy endpoints include analysis of the change in the individual cognitive tests as a function ... significant at Week 16 with an 11.7 percent change from baseline (p=0.052, versus placebo). The ...

HealthMedia and Aetna to Study Online Insomnia and Depression Interventions

... Inc., the global leader in scalable behavior change interventions with outcomes, announced a new ... to see if a Web-based based, cognitive behavior change program can decrease member reliance on sleep ... the general value of utilizing Web-based behavior change programs to treat both insomnia and depression. ...

Sangamo BioSciences Announces Presentation of Phase 1b ZFP Therapeutic Data at American Diabetes Association Meeting

... relevant improvement of 1.9 point change from baseline levels compared to a 0.7 point ... II is used as a method of assessing a subject's change in vibration sensitivity. Direct measurement of ... can be used to measure a clinically meaningful change in the neurological status of patients with DN ...

Study Shows Lantus(R) Helped People Living with Type 2 Diabetes Reach the ADA's Recommended Target for Blood Sugar Control

... +/- 0.7; 7.3 +/- 0.9; change -0.8 +/- 0.7 -0.2 +/- 0.9 ... +/- 33; 161 +/- 41; change -50 +/- 47 -5 +/- 39 ... +/- 13.4; 81.5 +/- 13.5; change +0.91 +/- 2.9 -2.5 +/- 3.2 Daily ...

Ironwood Pharmaceuticals and Forest Laboratories Announce Presentation of Linaclotide Phase 2b Chronic Constipation Study Results

... compared to placebo. The primary endpoint was the change from pre-treatment in weekly spontaneous bowel ... demonstrated a statistically significant change in weekly SBM frequency of 2.6 (75 mcg, p < ... with CC. The primary efficacy endpoint was the change in the overall mean weekly frequency of SBMs from ...

New Analysis in Boys and Girls Shows the ADHD Patch, DAYTRANA(TM) (methylphenidate transdermal system), Offered ADHD Symptom Control for 12 Months

... In the analysis, boys had a 41 percent change on the ADHD-RS-IV (as calculated from a mean baseline score of 11.6, with a mean change from baseline to endpoint of -4.8) and girls had a 23 percent change on the scale (as calculated from a mean baseline ...

Shire's Investigational Nonstimulant ADHD Treatment INTUNIV(TM) (Guanfacine Extended Release) Demonstrated Significant Efficacy in Reducing ADHD Symptoms at All Measured Time Points Up to 24 Hours Postdose

... The primary efficacy measure for both studies was change in the ADHD Rating Scale (ADHD-RS-IV) total score ... those participants receiving placebo. Using the change in the ADHD-RS-IV total score from baseline to ... of risks and uncertainties and are subject to change at any time. In the event such risks or ...

Data Presented at the American Psychiatric Association (APA) Annual Meeting Demonstrate Iloperidone's Efficacy and Safety, With Low Rates of Movement and Metabolic Adverse Events

... were observed with rs11851892 (NPAS3) with a change from baseline to endpoint PANSS-T score of ... value were seen with rs9643483 (XKR4) with a change from baseline to endpoint PANSS-T score of ... (CGI-S) (5) Clinical Global Impression of change (CGI-C) (6) Barnes Akathisia Scale (BAS) (7) ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... therapy studies (Studies 6 and 7) used the change in Montgomery-Asberg Depression Rating Scale ... advantage versus placebo plus an AD for 1) change in MADRS total score at Week 6 (-14.70 versus ... 150 mg/day, 300 mg/day, or placebo. The mean change from baseline to week 8 in HAM-A total score ...