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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Valsartan/amlodipine 160/5 mg
Valsartan 160 mg
Placebo
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Blood pressure, hypertension, Exforge, valsartan/amlodipine

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative site in Romainia
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Other

Arm Label

Valsartan 160 mg

Valsartan/amlodipine 160/5 mg

Single-Blind Run-In Valsartan 160 mg

Arm Description

One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks

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

Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
October 15, 2009
Last Updated
May 18, 2011
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT01001572
Brief Title
Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Blood pressure, hypertension, Exforge, valsartan/amlodipine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
932 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valsartan 160 mg
Arm Type
Active Comparator
Arm Description
One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Arm Title
Valsartan/amlodipine 160/5 mg
Arm Type
Experimental
Arm Description
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
Arm Title
Single-Blind Run-In Valsartan 160 mg
Arm Type
Other
Arm Description
Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Valsartan/amlodipine 160/5 mg
Other Intervention Name(s)
Exforge® 160/5mg
Intervention Description
Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
Intervention Type
Drug
Intervention Name(s)
Valsartan 160 mg
Other Intervention Name(s)
Diovan® 160mg
Intervention Description
Valsartan 160 mg capsule taken orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule or tablet taken orally once daily
Primary Outcome Measure Information:
Title
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
Description
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.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
Description
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
Time Frame
Baseline and Week 8
Title
Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
Description
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.
Time Frame
Baseline and Week 8
Title
Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
Description
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.
Time Frame
Week 8
Title
Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
Description
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.
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Investigative site in Romainia
Facility Name
Novartis Investigative Site

12. IPD Sharing Statement

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

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