Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension - Full Text View

Purpose

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone.

Condition	Intervention	Phase
Essential Hypertension	Drug: Valsartan/amlodipine 160/5 mg Drug: Valsartan 160 mg Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.

Secondary Outcome Measures:

Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate
Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.
Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.
Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.

Enrollment:	932
Study Start Date:	September 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Valsartan 160 mg One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks	Drug: Valsartan 160 mg Valsartan 160 mg capsule taken orally once daily. Other Name: Diovan® 160mg Drug: Placebo 1 capsule or tablet taken orally once daily
Experimental: Valsartan/amlodipine 160/5 mg One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks	Drug: Valsartan/amlodipine 160/5 mg Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily. Other Name: Exforge® 160/5mg Drug: Placebo 1 capsule or tablet taken orally once daily
Single-Blind Run-In Valsartan 160 mg Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.	Drug: Valsartan 160 mg Valsartan 160 mg capsule taken orally once daily. Other Name: Diovan® 160mg

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must give written informed consent
Male or female ages 18 or older and less than 86 years
Diagnosed as having essential diastolic hypertension, as follows:
- Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and < 100 mmHg
- At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP >=90 mmHg and <110 mmHg

Exclusion Criteria:

Severe hypertension
Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
Malignant hypertension
Administration of any agent indicated for the treatment of hypertension after Visit 1
Known moderate or malignant retinopathy.
Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001572

Locations

China
Novartis Investigative Site
TBD, China
Philippines
Novartis Investigative Site
TBD, Philippines
Romania
Investigative site in Romainia
TBD, Romania

Sponsors and Collaborators

Novartis

Investigators

Study Director:

Novartis Pharmaceuticals

Sponsor GmbH

More Information

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01001572 History of Changes
Other Study ID Numbers:	CVAA489A2317
Study First Received:	October 15, 2009
Results First Received:	April 22, 2011
Last Updated:	May 18, 2011
Health Authority:	China: Food and Drug Administration Romania: National Medicines Agency Philippines: Bureau of Food and Drugs

Keywords provided by Novartis:

Blood pressure
hypertension
Exforge
valsartan/amlodipine

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