8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension
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...
Brief Summary
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.”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: August 2007
Intervention(s) in this Clinical Trial
- Drug: Valsartan + amlodipine
- Drug: Valsartan + HCTZ
- Drug: Amlodipine + HCTZ
- Drug: Valsartan + amlodipine + HCTZ
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline diastolic blood pressure after 8 weeks
- Change from baseline systolic blood pressure after 8 weeks
Secondary Measures
- Blood pressure less than 140/90 mmHg after 8 weeks
- Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks
- 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
- Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements
- Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 85 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Principal Investigator Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00327587
Study ID Number: CVEA489A2302
ClinicalTrials.gov Identifier: NCT00327587
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00327587
