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Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00409643
First received: December 7, 2006
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

This trial will compare valsartan and amlodipine combination therapies to valsartan and amlodipine monotherapy,and placebo for treating patients with hypertension


Condition Intervention Phase
Hypertension
 Drug: valsartan+amlodipine combination
Drug: valsartan
Drug: amlodipine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Multifactorial, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan (160 mg and 320 mg) and Amlodipine (10 mg) Combined and Alone in Hypertensive Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8).

Secondary Outcome Measures:
  • Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (endpoint-Wk 8)
  • Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(endpoint-Wk 8)
  • Sitting and standing pulse

Enrollment: 1259
Study Start Date: January 2004
Study Completion Date: July 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 essential diastolic hypertension measured by calibrated standard aneroid or mercury (preferable) sphygmomanometer. Patients must have a MSDBP > 90 mmHg and < 110 mmHg at Visit 1 (week -4 to -2), 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 (MSDBP 110 mmHg and/or MSSBP 180 mmHg) at anytime.
  • Inability to discontinue all prior antihypertensive 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 0 (week -6 to -4).
  • Transient ischemic cerebral attack during the last 12 months prior to Visit 0 (week -6 to -4).
  • Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing Disease, pheochromocytoma, polycystic kidney disease 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 -4 to -2).
  • 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 -6 to -4).
  • Known or suspected contraindications, including history of allergy to angiotensin receptor blockers or calcium channel blockers.
  • Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00409643

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Germany
Sites in Germany
Germany, Germany
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis pharmaceuticals Sponsor GmbH
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00409643     History of Changes
Other Study ID Numbers: CVAA489A2307
Study First Received: December 7, 2006
Last Updated: November 7, 2011
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
HYPERTENSION, VALSARTAN, AMLODIPINE, high blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Amlodipine, valsartan drug combination
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 23, 2013