CLINICAL TRIALS
Figure 11: Cardiovascular trials initiated in the past 12 months by disease
60
By Gail Parziale, Citeline’s cardiovascular director
In the cardiovascular therapeutic area, a total of 211 industry-
Phase III
sponsored Phase II to Phase III trials were initiated between
50
September 1st, 2007, and August 31st, 2008. Of these,
hypertension, dyslipidemia and thrombotic disorders were the
Phase II/III
top three indications. In hypertension, 61% of the trials
initiated were Phase III studies, with Novartis being the most
40
significant contributor, followed by Actelion, Takeda and
ts
Phase II
Boehringer Ingelheim, all of which had three or more Phase III
starts during the study period. In dyslipidemia, 53% of the trials
30 initiated were Phase III, with Sanofi-Aventis and Merck & Co
each contributing at least four trials, and Abbott and the Isis
T
rial star
Pharmaceuticals/Genzyme collaboration each contributing
three. In thrombotic disorders, 59% of the trials initiated were
20
Phase III programmes. Sanofi-Aventis accounted for 25%
alone with eight trial starts, followed by Boehringer Ingelheim
with four, and the Bristol-Myers Squibb/Pfizer collaboration
10
contributing three. As depicted in Figure 11, the majority of
trial starts in the remaining cardiovascular diseases are more
heavily weighted in Phase II.
0
e
ders
omes
tension t failur
ythmia
rh y disease
Ar
Hyper
Dyslipidemia
ter
e hear
y syndr terial disease
y ar
ombotic disor
onar
Thr
Multiple CV diseases onar
Congestiv
Haemostasis/haemophilia
Cor
Acute cor
P
eripheral ar
Source: TrialTrove; accessed September 16th, 2008
Figure 12: Cardiovascular trials initiated in the past 12 months by company (top 20; Phases II-III)
15
Phase III
Among the companies with at least 10 trials initiated in the
12
past 12 months, Sanofi-Aventis is the clear leader, with 15
Phase III starts. Almost 50% involve registrational studies of
Phase II/III
AVE5026 for thrombotic disorders and nearly 25% are
registrational studies of AVE5530 for dyslipidemia. Novartis is
in second place with 11 trials heavily concentrated in
9
Phase II
hypertension. Most of the company’s Phase III trials are
ts focused on label expansions for aliskiren, while earlier stage
trials are focused on the new molecular entities LCZ696 and
LCI699. Boehringer Ingelheim had 10 trial starts, most being
T
rial star evenly distributed between label expansions for dabigatran in
6
thrombotic disorders and registrational studies of the
telmisartan/amlodipine fixed-dose combination (FDC) for
hypertension. Of the 10 GlaxoSmithKline trial starts, only one
involved a pipeline drug – a Phase III study of the Coreg CR/
3
lisinopril FDC for hypertension. The remaining GSK trials
involved various marketed drugs scattered across various
cardiovascular diseases. It is noteworthy that two of the top
20 companies by trial starts involve collaborations. Bristol-
Myers Squibb/Pfizer had three Phase III starts involving
0
apixaban in thrombotic disorders and Isis Pharmaceuticals/
tis
o
eda y
er
Genzyme had the same count for mipomersen in
v
entis
var Ba
y
eth
vier Eisai
Roche Pf_izer
dyslipidemia.
No
ck & Co
T
ak
Actelion
Abbott
W
Ser
Pf_izer
peutics
Genzyme
Mer
Sanof_i-A
AstraZeneca Thera
GlaxoSmithKline
Schering-Plough
Daiichi Sanky
ers Squibb;
Boehringer Ingelheim
United
Aegerion Pharmaceuticals
Anthera Pharmaceuticals
Bristol-My
Isis Pharmaceuticals;
Source: TrialTrove; accessed September 16th, 2008
www.scripnews.com/supplements Scrip 100
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