Safety and Efficacy of Valsartan and Amlodipine Combined and Alone in Patients With Hypertension. - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00409760

Purpose

This trial will compare valsartan and amlodipine combination therapies to both valsartan and amlodipine, and placebo for the treatment of hypertension.

Condition	Intervention	Phase
Hypertension	Drug: valsartan+amlodipine combination, valsartan, amlodipine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multicenter, Multifactorial, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Valsartan and Amlodipine Combined and Alone in Hypertensive Patients.

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan Exforge

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 (Wk 4 and Wk 8)

Secondary Outcome Measures:

Change from baseline (Visit 2) in mean sitting systolic blood pressure at trough (Wk 4 and Wk 8)
Change from baseline (Visit 2) in standing diastolic and systolic blood pressure at trough(Wk 4 and Wk 8)
Sitting and standing pulse

Estimated Enrollment:	1850
Study Start Date:	August 2005

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 mild to moderate essential diastolic hypertension (grades 1 and 2 WHO classification) measured by calibrated standard sphygmomanometer.
Patients must have a MSDBP  90 mmHg and < 110 mmHg at Visit 1 (week –2 to –4), 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 (grade 3 WHO classification; MSDBP 110 mmHg diastolic and/or MSSBP  180 mmHg systolic).
Inability to discontinue all prior anti-hypertensive 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 1 (week -2 to
4).
Transient ischemic cerebral attack during the last 12 months prior to Visit 1 (week -2 to -4).
Evidence of a secondary form of hypertension, such as coarctation of the aorta, hyperaldosteronism, unilateral renal artery stenosis, or pheochromocytoma, 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 -2 to -4).
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 -4 to -6).
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: NCT00409760

Locations

Germany
Sites in Germany
sites in Germany, Germany

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis pharmaceuticals

Sponsor GmbH

More Information

Additional Information:

NOVARTIS PATIENT RECRUITMENT WEBSITE This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CVAA489A2201
Study First Received:	December 7, 2006
Last Updated:	July 6, 2007
ClinicalTrials.gov Identifier:	NCT00409760 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

HYEPRTENSION, VALSARTAN, AMLODIPINE, high blood pressure

Study placed in the following topic categories:

Calcium, Dietary
Vasodilator Agents
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents

Antihypertensive Agents
Valsartan
Amlodipine
Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on September 01, 2009