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8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

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ClinicalTrials.gov Identifier: NCT00327587
Recruitment Status : Completed
First Posted : May 18, 2006
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan + amlodipine Drug: Valsartan + HCTZ Drug: Amlodipine + HCTZ Drug: Valsartan + amlodipine + HCTZ Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.
Study Start Date : May 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

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Primary Outcome Measures :
  1. Change from baseline diastolic blood pressure after 8 weeks
  2. Change from baseline systolic blood pressure after 8 weeks

Secondary Outcome Measures :
  1. Blood pressure less than 140/90 mmHg after 8 weeks
  2. Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
  3. Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks
  4. Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
  5. Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and < 120 mmHg, MSSBP ≥ 145 mmHg and < 200 mmHg).

Exclusion Criteria:

  • Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
  • Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and < 110 mmHg, and/or MSSBP ≥ 140 mmHg and < 180 mmHg at Visit 1.
  • Patients on four or more antihypertensive drugs at Visit 1.
  • Arm circumference > 42 cm for patients participating in ABPM.

Other protocol-defined 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 ClinicalTrials.gov identifier (NCT number): NCT00327587


Locations
United States, New Jersey
Novartis Pharmaceuticals Corporation
E. Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00327587     History of Changes
Other Study ID Numbers: CVEA489A2302
First Posted: May 18, 2006    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by Novartis:
hypertension
valsartan
amlodipine
HCTZ

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors