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Effectiveness of a Valsartan Based Versus an Amlodipine Based Treatment Strategy in naïve Patients With Stage 1 or Stage 2 Hypertension or in Patients Uncontrolled on Current Monotherapy

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: NCT00304226
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):

Brief Summary:

The population for this current study will include stage 1 and stage 2 hypertensive patients who are newly diagnosed or didn't have treatment during the last 3 months and patients who are currently treated but uncontrolled on present monotherapy.

The purpose of this study is to evaluate the efficacy of a treatment with valsartan versus a treatment with amlodipine in reaching blood pressure control after 14 weeks of treatment.

Condition or disease Intervention/treatment Phase
Hypertension Drug: valsartan Drug: amlodipine Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 14 Week Study to Evaluate Effectiveness of a Valsartan Versus an Amlodipine Treatment Strategy in Achieving Blood Pressure Control in Patients With Stage 1 or Stage 2 Hypertension or Uncontrolled on Present Monotherapy
Study Start Date : February 2006
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Blood pressure less than 140/90 mmHg after 14 weeks

Secondary Outcome Measures :
  1. Blood pressure less than 140/90 mmHg after 4, 8, and 11 weeks
  2. Blood pressure less than 140/90 mmHg after 4, 8, 11, and 14 weeks
  3. Time when blood pressure reaches less than 140/90 mmHg
  4. Change in blood pressure at baseline, week 4, 8, 11, and 14
  5. Adverse events and serious adverse events at each study visit for 14 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion criteria Stage/grade 1 or stage/ grade 2 hypertension, MSSBP ≥ 140 mm Hg, and/ or MSDBP ≥ 90 mm Hg, at Visit 1 and 2 in untreated patients Or Patients who are currently treated on monotherapy and uncontrolled and have a blood pressure ≤ 160/100 mm Hg at Visit 1 and Visit 2

Exclusion criteria Current treatment with a CCB MSSBP ≥ 180 mm Hg or MSDBP ≥ 110 mm Hg at any time between visit 1 and Visit 2 History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures Evidence of a secondary form of hypertension Cerebrovascular accident or myocardial infarction during the last 12 months, prior to Visit 1 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): NCT00304226

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Investigative Centers, Germany
Novartis Pharmaceuticals
Basel, Switzerland
Sponsors and Collaborators
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Study Director: Novartis Pharmaceuticals Novatis Pharmaceuticals

Additional Information:
Publications of Results:
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Responsible Party: Novartis Identifier: NCT00304226     History of Changes
Other Study ID Numbers: CVAH631B2406
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: November 2016
Keywords provided by Novartis:
Additional relevant MeSH terms:
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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