Navigation Links
Amlodipine and Olmesartan Study Results Released;Late Breaker,Presented at American Society of Hypertension Twenty-Second Annual,Scientific Meeting (ASH 2007)

First Release of Data for New Combination

PARSIPPANY, NJ (May 21, 2007) -- Combining the calcium channel blocker amlodipine besylate with the angiotensin receptor blocker olmesartan medoxomil, produced significant mean reductions in seated systolic and diastolic blood pressure in patients with hypertension, according to data presented at the American Society of Hypertension’s Twenty-Second Annual Scientific Meeting and Exposition (ASH 2007). The Phase III registration trial data was presented for the first time at today’s “late breaker” session at the ASH meeting in Chicago. Daiichi Sankyo, Inc. filed a New Drug Application (NDA) in November 2006 for a fixed-dose combination of the two antihypertensives. This investigational agent of amlodipine besylate/olmesartan medoxomil (AZOR™) is under regulatory review in the United States, including trade name review.

“All combinations of amlodipine and olmesartan produced significantly greater mean reductions in both diastolic and systolic blood pressure than either medication alone,” said Steven G. Chrysant, MD, of the Oklahoma Cardiovascular and Hypertension Center and the University of Oklahoma School of Medicine, and lead investigator on the study. “All combinations with amlodipine 10 mg demonstrated a lower incidence of edema versus amlodipine 10 mg monotherapy,” he added.

Amlodipine 10 mg/day plus olmesartan 40 mg/day reduced systolic blood pressure an average of 30.1 mm Hg and the diastolic reading an average of 19.0 mm Hg. These results were in comparison w ith mean reductions of 19.7 mm Hg systolic/12.7 mm Hg diastolic for amlodipine 10 mg alone (placebo= 4.8/3.1 mm Hg). When compared to amlodipine 10 mg alone, amlodipine 10 mg/day plus olmesartan 40 mg/day resulted in a 53 percent greater reduction in systolic blood pressure. Amlodipine combined with olmesartan provides two complimentary mechanisms of action to lower blood pressure: calcium channel blockade with amlodipine and angiotensin receptor blockade with olmesartan.

The AE profile for each of the combinations was similar in nature to the monotherapy components. Most reported treatment-emergent adverse events across all treatment groups were considered mild in severity.

Hypertension, also known as high blood pressure, affects approximately 72 million people in the United States and approximately one billion worldwide. It is often difficult to control, and of those diagnosed with high blood pressure, 64.9 percent do not have the condition under control.1

Study Design

The study was a Phase III, 8-week, randomized, double-blind, placebo-controlled, parallel-group, factorial study in 1,940 patients with mild to severe hypertension defined as seated diastolic BP between ? 95 mm Hg and ? 120 mm Hg. The purpose of the study was to determine if co-administration of amlodipine 5-10 mg/day and olmesartan 10-20-40 mg/day had a significant benefit vs. its respective monotherapy components. Primary and one of the secondary endpoints were mean change from baseline in seated diastolic and seated systolic blood pressure at week 8, respectively.

About Daiichi Sankyo, Inc.

Daiichi Sankyo, Inc., headquartered in Parsippany, New Jersey, is the U.S. subsidiary of Daiichi Sankyo Co., Ltd., Japan’s second largest pharmaceutical company and a global leader in pharmaceutical innovation since 1899. The company is dedicated to the discovery, development and commercialization of innovative medicines that improve the lives of patients throughout the world.

The primary focus of Daiichi Sankyo’s research and development is cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. The company is also pursuing the discovery of new medicines in the areas of glucose metabolic disorders, infectious diseases, cancer, bone and joint diseases, and immune disorders.

For more information, please visit

# # #

1. Site accessed 5/10/2007

Bill Heineke Jason Ford

(708) 366-9985 Daiichi Sankyo, Inc.

(708) 308-0572 (cell) (973) 359-2634 (908) 868 4554 (cell)

Patty Bifulco

Hill & Knowlton

(212) 885-0494

(917) 626-2780 (cell)


Related medicine technology :

1. Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril
2. Amlodipine and Olmesartan Study Results Released; Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007)
3. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
4. Clinical Study Shows Regenecare Relieves Pain and Itching of Skin Rashes Caused by Widely Used Cancer Drugs
5. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
6. Biofrontera AG Announces Clinical Study Confirms Excellent Efficacy of BF-200 ALA In Actinic Keratosis
7. Reaction to Avandia Warnings Stronger Among Internists Than Endocrinologists, According to Study by GfK Market Measures
8. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
9. Actemra (tocilizumab) Third Phase III Study Results Show Significant Improvement in Symptoms of Patients with Rheumatoid Arthritis
10. Protox Announces Positive Clinical Data from Prostate Cancer Study
11. International ENDORSE Study Shows That the Majority of Hospitalized Patients Surveyed are at Risk for VTE and Many do not Receive Recommended VTE prophylaxis
Post Your Comments:
(Date:6/23/2016)... LOS ANGELES , June 23, 2016 /PRNewswire/ ... (NASDAQ: CAPR ), a biotechnology company ... first-in-class therapeutics, today announced that patient enrollment in ... progrEssion in Duchenne) has exceeded 50% of its ... its enrollment in the third quarter of 2016, ...
(Date:6/23/2016)... INDIANAPOLIS , June 23, 2016 If ... Leaders Scholarship is any indication, the future is in ... at by the Diabetes Scholars Foundation ... the way of academic and community service excellence. ... since 2012, and continues to advocate for people with ...
(Date:6/23/2016)... , June 23, 2016 The vast ... an outpatient dialysis facility.  Treatments are usually 3 times ... hours per visit, including travel time, equipment preparation and ... patient, but especially grueling for patients who are elderly ... a skilled nursing and rehabilitation centers for some duration ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts ... applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention ... health care topics including advance care planning, healthcare costs and patient and family ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/24/2016)... ... , ... Those who have experienced traumatic events may suffer from a complex ... as drug or alcohol abuse, as a coping mechanism. To avoid this pain and ... a traumatic event. , Trauma sufferers tend to feel a range of emotions, from ...
(Date:6/24/2016)... ... June 24, 2016 , ... Dr. Amanda Cheng, an ... Cheng has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be ...
Breaking Medicine News(10 mins):