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

NCT00409643 | Completed Phase 3

• 1 other identifier: CVAA489A2307
• Study Type: interventional
• Target: 1,259
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Hypertension

Keywords

HYPERTENSION, VALSARTAN, AMLODIPINE, high blood pressure

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

valsartan+amlodipine combination DRUG

valsartan DRUG

amlodipine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Sites in Germany

Germany, Germany

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug Combination; Valsartan; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Novartis pharmaceuticals

  Sponsor GmbH

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2006
• First Posted: December 11, 2006
• Study Start: January 1, 2004
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: November 8, 2011

Record last verified: 2011-11

Locations

DE (1); US (1)