Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00409760
Recruitment Status : Completed
First Posted : December 11, 2006
Last Update Posted : November 23, 2011
Information provided by (Responsible Party):

December 7, 2006
December 11, 2006
November 23, 2011
January 2003
February 2004   (Final data collection date for primary outcome measure)
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (Wk 4 and Wk 8)
Same as current
Complete list of historical versions of study NCT00409760 on Archive Site
  • Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (Wk 4 and Wk 8)
  • Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(Wk 4 and Wk 8)
  • Sitting and standing pulse
Same as current
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Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension.
A Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.
This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: valsartan+amlodipine combination, valsartan, amlodipine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2004
February 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 is disallowed.
  • Patients with mild to moderate essential diastolic hypertension (grades 1 and 2 WHO classification) measured by calibrated standard sphygmomanometer.
  • Patients must have a MSDBP >= 90 mmHg and < 110 mmHg at Visit 1 (week -2 to -4), and a MSDBP >= 95 mmHg and < 110 mmHg at Visit 2 (week 0).
  • 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).

Exclusion Criteria:

  • Severe hypertension (grade 3 WHO classification; MSDBP >=110 mmHg diastolic and/or MSSBP >= 180 mmHg systolic).
  • Inability to discontinue all prior anti-hypertensive medications safely for a period of 14 weeks).
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy or cerebrovascular accident at anytime prior to Visit 1 (week -2 to -4).
  • Transient ischemic cerebral attack during the last 12 months prior to Visit 1 (week -2 to -4).
  • Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, 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 -2 to -4).
  • 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 -4 to -6).
  • Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
  • Other protocol-defined inclusion/exclusion criteria may apply
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Chair: Novartis pharmaceuticals Sponsor GmbH
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP