Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001572
• Other study ID #: CVAA489A2317
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: May 18, 2011
• Start date: September 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationRomania: National Medicines AgencyPhilippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 932
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Valsartan/amlodipine 160/5 mg
Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
• Valsartan 160 mg
Valsartan 160 mg capsule taken orally once daily.
• Placebo
1 capsule or tablet taken orally once daily

Locations

Country	Name	City	State
China	Novartis Investigative Site	TBD
Philippines	Novartis Investigative Site	TBD
Romania	Investigative site in Romainia	TBD

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

China,  Philippines,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint	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.	Baseline and Week 8	No
Secondary	Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint	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	Baseline and Week 8	No
Secondary	Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint	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.	Baseline and Week 8	No
Secondary	Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint	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.	Week 8	No
Secondary	Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint	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.	Week 8	No