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

December 7, 2006
November 7, 2011
January 2004
July 2004   (final data collection date for primary outcome measure)
Change from baseline (Visit 2) in mean sitting diastolic blood pressure at trough (endpoint-Week 8).
Same as current
Complete list of historical versions of study NCT00409643 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
  • Drug: valsartan+amlodipine combination
  • Drug: valsartan
  • Drug: amlodipine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1259
July 2004
July 2004   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00409643
CVAA489A2307
Not Provided
Novartis
Novartis
Not Provided
Study Chair: Novartis pharmaceuticals Sponsor GmbH
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP