BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Data from Phase 3 Studies of Investigational Fixed-Dose Combination of Azilsartan Medoxomil Plus Chlorthalidone Presented at the American Society of Hypertension Annual Scientific Meeting


5/23/2011 8:37:30 AM

DEERFIELD, Ill., May 23, 2011 /PRNewswire/ -- Takeda Global Research & Development Center, Inc. U.S., (TGRD U.S.) today announced results from three phase 3 studies of the investigational fixed-dose combination of azilsartan medoxomil plus chlorthalidone (CLD). In two phase 3 studies, azilsartan medoxomil combined in a fixed-dose with CLD lowered clinic systolic blood pressure (SBP) significantly more than the fixed-dose combination of olmesartan medoxomil plus hydrochlorothiazide (HCTZ). Another phase 3 study demonstrated that six fixed-dose combinations of azilsartan medoxomil plus CLD lowered mean trough (22-24 hours) SBP by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) significantly more than either azilsartan medoxomil or CLD alone.

Discovered by Takeda, azilsartan medoxomil is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone. Chlorthalidone is a long-acting diuretic used in the treatment of hypertension. All studies were presented at the American Society of Hypertension, Inc. (ASH) Twenty-Sixth Annual Scientific Meeting and Exposition (ASH 2011) in New York.

"We were pleased with the results of the fixed-dose combination of azilsartan medoxomil plus chlorthalidone studies," said Domenic Sica, M.D., professor of internal medicine and nephrology at Virginia Commonwealth University Medical Center and lead investigator of the study. "If approved, the fixed-dose combination of azilsartan medoxomil plus chlorthalidone will be the first and only fixed-dose therapy in the U.S. that combines an ARB with the diuretic, chlorthalidone. This combination therapy can potentially provide a new treatment option for the millions of patients who are at risk of serious health consequences due to hypertension."

A New Drug Application, which was supported by five phase 3 clinical trials involving more than 5,000 patients with hypertension, was submitted to the Food and Drug Administration (FDA) for the fixed-dose combination of azilsartan medoxomil plus CLD in February 2011.

Fixed-Dose Combination of Azilsartan Medoxomil Plus CLD vs. Fixed-Dose Combination of Olmesartan Medoxomil and HCTZ (Forced titration) (LB-OR-03)

This phase 3, 12-week, randomized, double-blind study evaluated clinic SBP reductions of the fixed-dose combination of azilsartan medoxomil plus CLD and a fixed-dose combination of olmesartan medoxomil and HCTZ in 1,071 patients with hypertension.

In the two azilsartan medoxomil plus CLD fixed-dose combination groups, patients were force titrated from 20/12.5 mg and 40/12.5 mg to 40/12.5 mg and 80/12.5 mg at week 4, and to 40/25 mg and 80/25 mg at week 8, respectively. In the olmesartan medoxomil and HCTZ fixed-dose combination group, patients were force titrated from 20/12.5 mg to 40/12.5 mg at week 4 and to 40/25 mg at week 8.

Results, at week 12, showed that the two azilsartan medoxomil plus CLD fixed-dose combination groups reduced clinic SBP by 42.5 mm Hg and 44.0 mm Hg from baseline. The reductions were significantly greater than that of the fixed-dose combination of olmesartan medoxomil and HCTZ (37.1 mm Hg).

Adverse events leading to temporary or permanent drug discontinuation occurred in 7.9 and 14.5 percent in the two groups of patients taking the fixed-dose combination of azilsartan medoxomil plus CLD and 7.1 percent of patients taking olmesartan medoxomil combined in a fixed-dose with HCTZ.

Fixed-Dose Combination of Azilsartan Medoxomil Plus CLD vs. Fixed-Dose Combination of Olmesartan Medoxomil and HCTZ (Poster #162)

This phase 3, eight-week, randomized, double-blind study evaluated clinic SBP reductions of the fixed-dose combination of azilsartan medoxomil plus CLD and a fixed-dose combination of olmesartan medoxomil and HCTZ in 1,085 patients with stage 2 hypertension.

In the two azilsartan medoxomil plus CLD fixed-dose combination groups, patients were titrated from 20/12.5 mg and 40/12.5 mg to 40/25 mg and 80/25 mg, respectively, at week four if they had not reached their target blood pressure goals. In the olmesartan medoxomil and HCTZ fixed-dose combination group, patients were titrated from 20/12.5 mg to 40/25 mg at week four if they had not reached their target blood pressure goals.

Results showed that the two azilsartan medoxomil plus CLD fixed-dose combination groups reduced clinic SBP by 37.6 and 38.2 mm Hg from baseline at week eight. The reductions were significantly greater than that of the fixed-dose combination of olmesartan medoxomil and HCTZ (31.5 mm Hg). Fewer patients in the azilsartan medoxomil fixed-dose combination groups were titrated at week four to a higher dose than in the olmesartan medoxomil and HCTZ fixed-dose combination group.

Adverse events leading to temporary or permanent drug discontinuation occurred in 6.2 percent and 9.5 percent in the two groups of patients taking the fixed-dose combination of azilsartan medoxomil plus CLD, and 3.1 percent of patients taking olmesartan medoxomil combined in a fixed-dose with HCTZ.

Fixed-Dose Combination of Azilsartan Medoxomil Plus CLDvs. Azilsartan Medoxomil and CLD Monotherapies (Poster #182)

This phase 3, eight-week, randomized, double-blind, factorial study evaluated various fixed-dose combinations of azilsartan medoxomil plus CLD in 1,714 patients with stage 2 hypertension. The change in trough (22-24 hours) SBP by 24-hour ABPM from baseline to week eight was examined as a primary endpoint among six different fixed-dose combinations of azilsartan medoxomil 20 mg/day, 40 mg/day and 80 mg/day plus CLD 12.5 and 25 mg/day.

The study demonstrated the six fixed-dose combinations of azilsartan medoxomil plus CLD lowered trough SBP by a range of 22.9 mm Hg to 29.8 mm Hg from baseline at week eight. All reductions were significantly greater than those of azilsartan medoxomil monotherapies (12.1 mm Hg to 15.1 mm Hg) or CLD monotherapies (12.7 mm Hg to 15.9 mm Hg).

Adverse events leading to temporary or permanent drug discontinuation occurred more frequently in the azilsartan medoxomil plus CLD combination groups (3.4-14.3 percent) compared to the monotherapy groups [azilsartan medoxomil monotherapy (1.9-4.3 percent); CLD monotherapy (1.9-3.8 percent)]. Increases in serum creatinine occurred more frequently with the fixed-dose combinations of azilsartan medoxomil plus CLD relative to either monotherapy agent, and were dose-dependent.

About Hypertension

Hypertension, or high blood pressure, is a chronic medical condition in which blood pressure is elevated to levels of 140 mm Hg or greater systolic or 90 mm Hg or greater diastolic. If left uncontrolled, hypertension can lead to serious health problems, including heart attack and stroke.Hypertension impacts approximately 75 million Americans, or nearly one in three adults. It is estimated that nearly one billion people are affected by hypertension worldwide, and this figure is predicted to increase to 1.5 billion by 2025. Hypertension typically has no symptoms. Adults of all ages and backgrounds can develop hypertension; however, the risk of developing the condition increases with age, with more than half of people over age 60 affected. Hypertension is also costly to the nation's health care system. The American Heart Association recently estimated that direct and indirect expenses associated with hypertension cost the nation more than $73 billion in 2009.

About Fixed-Dose Combination of Azilsartan Medoxomil Plus Chlorthalidone

Developed by Takeda, azilsartan medoxomil plus chlorthalidone (CLD) is an investigational fixed-dose combination for the treatment of hypertension, or high blood pressure. The fixed-dose combination of azilsartan medoxomil plus CLD contains two medications: azilsartan medoxomil, an angiotensin II receptor blocker, and chlorthalidone, a long-acting diuretic used in the treatment of hypertension. The most commonly reported adverse drug reactions occurring in at least two percent of the fixed-dose combination of azilsartan medoxomil plus CLD-treated patients at the submitted recommended doses and greater than azilsartan medoxomil or chlorthalidone monotherapies were increased blood creatinine (11 percent), dizziness (8.2 percent), increased blood uric acid (3.8 percent), increased blood urea (2.8 percent) and fatigue (2.5 percent). Most elevations of creatinine were transient and were generally associated with large blood pressure reductions. The azilsartan medoxomil plus CLD fixed-dose combination New Drug Application was submitted to the Food and Drug Administration in February 2011 and was supported by five phase 3 clinical trials involving more than 5,000 patients with hypertension.

About Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc.

Based in Deerfield, Ill., Takeda Pharmaceuticals North America, Inc. and Takeda Global Research & Development Center, Inc. are subsidiaries of Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan. The respective companies currently market oral diabetes, insomnia, rheumatology, gastroenterology and cardiovascular treatments and seek to bring innovative products to patients through a pipeline that includes compounds in development for metabolic and cardiovascular disease, gastroenterology, neurology and other conditions. To learn more about these Takeda companies, visit www.tpna.com.

Elissa J. Johnsen
Takeda Pharmaceuticals North America
224-554-3185
ejohnsen@tpna.com

Josephine Zammuto
Takeda Global Research & Development
224-554-2795
josephine.zammuto@tpna.com

Ashleigh Duchene
GolinHarris
312-729-4428
aduchene@golinharris.com

SOURCE Takeda Global Research & Development Center, Inc. U.S.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES