Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: valsartan+amlodipine combination (Drug); valsartan (Drug); amlodipine (Drug)
Phase: Phase 3
Sponsored by: Novartis
Official(s) and/or principal investigator(s):
Novartis pharmaceuticals, Study Chair, Affiliation: Sponsor
This trial will compare valsartan and amlodipine combination therapies to valsartan and
amlodipine monotherapy,and placebo for treating patients with hypertension
Official title: A Randomized, Double-Blind, Multicenter, Multifactorial, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8).
Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (endpoint-Wk 8)
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(endpoint-Wk 8)
Sitting and standing pulse
Minimum age: 18 Years.
Maximum age: N/A.
- Outpatients 18 years and older.
- Male or female patients are eligible. Female patients must be either post-menopausal
for one year or surgically sterile, or using effective contraceptive methods such as
barrier method with spermicide or an intra-uterine device. Hormonal contraceptive use
- Patients with essential diastolic hypertension measured by calibrated standard aneroid
or mercury (preferable) sphygmomanometer. Patients must have a MSDBP > 90 mmHg and <
110 mmHg at Visit 1 (week - 4 to –2), and a MSDBP > 95 mmHg and < 110 mmHg at Visit 2
- Patients must have an absolute difference of > 10 mmHg in their average sitting
diastolic blood pressure between Visits 1 and 2.
- Patients who are eligible and able to participate in the study, and who consent to do
so after the purpose and nature of the investigation has been clearly explained to
them (written informed consent).
- Severe hypertension (MSDBP 110 mmHg and/or MSSBP 180 mmHg) at anytime.
- Inability to discontinue all prior antihypertensive medications safely for a period of
- Known Keith-Wagener grade III or IV hypertensive retinopathy.
- History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to
Visit 0 (week - 6 to -4).
- Transient ischemic cerebral attack during the last 12 months prior to Visit 0 (week -6
to - 4).
- Evidence of a secondary form of hypertension, such as coarctation of the aorta,
hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing Disease,
pheochromocytoma, polycystic kidney disease etc.
- Type 1 diabetes mellitus.
- Type 2 diabetes mellitus with poor glucose control as defined by fasting glycosylated
hemoglobin (HbA1c) >8% at Visit 1 (week - 4 to -2).
- Administration of any agent indicated for the treatment of hypertension within a
minimum 4 weeks prior to randomization into the study (Visit 2, week 0), with the
permitted exception of those anti-hypertensive medications requiring tapering down
commencing at Visit 0 (week - 6 to -4).
- Known or suspected contraindications, including history of allergy to angiotensin
receptor blockers or calcium channel blockers.
- Other protocol-defined inclusion/exclusion criteria may apply
Locations and Contacts
Sites in Germany, Germany, Germany
Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States
Starting date: January 2004
Last updated: July 6, 2007