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Trial record 21 of 101 for:    AMLODIPINE AND VALSARTAN

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):

Brief Summary:
This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan+amlodipine combination, valsartan, amlodipine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1930 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : January 2003
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (Wk 4 and Wk 8)

Secondary Outcome Measures :
  1. Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (Wk 4 and Wk 8)
  2. Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(Wk 4 and Wk 8)
  3. Sitting and standing pulse

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00409760

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Sites in Germany
sites in Germany, Germany
Sponsors and Collaborators
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Study Chair: Novartis pharmaceuticals Sponsor GmbH

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Responsible Party: Novartis Identifier: NCT00409760     History of Changes
Other Study ID Numbers: CVAA489A2201
First Posted: December 11, 2006    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011
Keywords provided by Novartis:
Additional relevant MeSH terms:
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Amlodipine, Valsartan Drug Combination
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists