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Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Valsartan + amlodipine 40/2.5 mg
Valsartan + amlodipine 40/5 mg
Valsartan + amlodipine 80/2.5 mg
Valsartan + amlodipine 80/5 mg
Valsartan 40 mg
Valsartan 80 mg
Amlodipine 2.5 mg
Amlodipine 5 mg
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Hypertension, Valsartan, Amlodipine, high blood pressure

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria.

    1. MSDBP <110 mmHg and MSSBP <180 mmHg at Visit 1
    2. MSDBP ≥ 90 mmHg and < 110 mmHg and MSSBP < 180 mmHg at Visit 2
    3. MSDBP ≥ 95 mmHg and < 110 mmHg and MSSBP < 180 mmHg at Visit 3
    4. The absolute difference in MSDBP between Visit 2 and 3 is ≤ 10 mmHg
  • Male or female outpatients.
  • Aged => 20 and =< 80 years (at the time of signing informed consent).
  • Patients who have written informed consent to participate in this study.

Exclusion criteria

  • Pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential.
  • Patients with secondary hypertension or suspected of having secondary hypertension.
  • Patients with a history of malignant hypertension.
  • Patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol.
  • Patients with or with a history of any of the following diseases or signs: Cardiac disease, renal disease, cerebrovascular disorder
  • Patients with a clinically significant allergy (asthma on pharmacotherapy, multi-drug allergy, or drug-induced or food-induced anaphylactic reactions).
  • Patients hypersensitive to AII receptor antagonists, calcium channel blockers or dihydropyridine derivatives.
  • Known moderate or malignant retinopathy.
  • Patients with or with a history of pancreatitis. Patients with pancreatic injury, or evidence of impaired pancreatic function/injury within 12 months of Visit 1.
  • Patients with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
  • Patients with volume depletion based on the investigator's or subinvestigator's clinical judgment using vital signs, skin turgor, moistness of mucous membrane and laboratory values.
  • Patients who are found to have low Na and K (Na <130 mEq/L, K <3.3mEq/L) or high in these parameters (Na ≥ 152 mEq/L, K ≥ 5.2 mEq/L) by laboratory tests at Visit 1.
  • Patients with type I diabetes mellitus on treatment with insulin, or patients with type II diabetes with poor glucose control defined as a glycosylated hemoglobin (HbA1c) > 8.0% at Visit 1.
  • Patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin).
  • Patients with any severe, life-threatening disease within the past 5 years. Patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus.
  • Any surgical or medical condition, which in the opinion of the investigator or subinvestigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirement of the study or completing the trial period.
  • Patients who have with or with a history of drug or alcohol abuse within the last 2 years of Visit 1. Patients who have received other investigational product within 12 weeks of Visit 1.
  • Any chronic inflammatory condition needing chronic anti-inflammatory drug therapy.
  • Persons directly involved in the execution of this study.
  • Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or subinvestigator.

Sites / Locations

  • Novartis Pharmaceuticals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Valsartan + amlodipine 40/2.5 mg

Valsartan + amlodipine 40/5 mg

Valsartan + amlodipine 80/2.5 mg

Valsartan + amlodipine 80/5 mg

Valsartan 40 mg

Valsartan 80 mg

Amlodipine 2.5 mg

Amlodipine 5 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.

Secondary Outcome Measures

Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.

Full Information

First Posted
January 22, 2007
Last Updated
April 20, 2011
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00425373
Brief Title
Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension
Official Title
A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled, Factorial Study to Evaluate the Efficacy and Safety of 8-week Treatment With Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined and Alone in Essential Hypertensive Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies, and placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Hypertension, Valsartan, Amlodipine, high blood pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1474 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valsartan + amlodipine 40/2.5 mg
Arm Type
Experimental
Arm Title
Valsartan + amlodipine 40/5 mg
Arm Type
Experimental
Arm Title
Valsartan + amlodipine 80/2.5 mg
Arm Type
Experimental
Arm Title
Valsartan + amlodipine 80/5 mg
Arm Type
Experimental
Arm Title
Valsartan 40 mg
Arm Type
Active Comparator
Arm Title
Valsartan 80 mg
Arm Type
Active Comparator
Arm Title
Amlodipine 2.5 mg
Arm Type
Active Comparator
Arm Title
Amlodipine 5 mg
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Valsartan + amlodipine 40/2.5 mg
Intervention Description
Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Valsartan + amlodipine 40/5 mg
Intervention Description
Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Valsartan + amlodipine 80/2.5 mg
Intervention Description
Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Valsartan + amlodipine 80/5 mg
Intervention Description
Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Valsartan 40 mg
Intervention Description
Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Valsartan 80 mg
Intervention Description
Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Amlodipine 2.5 mg
Intervention Description
Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Amlodipine 5 mg
Intervention Description
Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 tablet and 2 capsule placebos taken once daily
Primary Outcome Measure Information:
Title
Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to End of Study (Week 8)
Description
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame
Baseline to end of study (Week 8)
Secondary Outcome Measure Information:
Title
Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to End of Study (Week 8)
Description
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame
Baseline to end of study (Week 8)
Title
Percentage of Patients Achieving MSDBP < 90 mmHg or a => 10 mm Hg Decrease Compared to Baseline at the End of the Study (Week 8)
Description
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame
Baseline to end of study (Week 8)
Title
Percentage of Patients Achieving MSDBP < 90mmHg at the End of the Study (Week 8)
Description
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame
Baseline to end of study (Week 8)
Title
Percentage of Patients Achieving MSDBP < 90 mm Hg and MSSBP < 140 mm Hg at the End of the Study (Week 8)
Description
At study entry, blood pressure was measured in both arms using a standard method described in the protocol. The arm with the higher diastolic BP reading was used for the measurements at all subsequent visits. Blood pressure in the sitting position was measured after resting in a seated position for at least 5 minutes. The measurement was repeated a total of 3 times at intervals of 1 to 2 minutes. A negative number indicates lowered blood pressure.
Time Frame
Baseline to end of study (Week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients with essential hypertension measured by electronic hemodynamometer. - - Patients must satisfy the following criteria. MSDBP <110 mmHg and MSSBP <180 mmHg at Visit 1 MSDBP ≥ 90 mmHg and < 110 mmHg and MSSBP < 180 mmHg at Visit 2 MSDBP ≥ 95 mmHg and < 110 mmHg and MSSBP < 180 mmHg at Visit 3 The absolute difference in MSDBP between Visit 2 and 3 is ≤ 10 mmHg Male or female outpatients. Aged => 20 and =< 80 years (at the time of signing informed consent). Patients who have written informed consent to participate in this study. Exclusion criteria Pregnant women, nursing (lactating) mothers, women suspected of being pregnant, or women who wish to be pregnant during the study, women of child-bearing potential. Patients with secondary hypertension or suspected of having secondary hypertension. Patients with a history of malignant hypertension. Patients with an inability to completely discontinue all prior antihypertensive medications safely for a period of 12 weeks as required by the protocol. Patients with or with a history of any of the following diseases or signs: Cardiac disease, renal disease, cerebrovascular disorder Patients with a clinically significant allergy (asthma on pharmacotherapy, multi-drug allergy, or drug-induced or food-induced anaphylactic reactions). Patients hypersensitive to AII receptor antagonists, calcium channel blockers or dihydropyridine derivatives. Known moderate or malignant retinopathy. Patients with or with a history of pancreatitis. Patients with pancreatic injury, or evidence of impaired pancreatic function/injury within 12 months of Visit 1. Patients with any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug. Patients with volume depletion based on the investigator's or subinvestigator's clinical judgment using vital signs, skin turgor, moistness of mucous membrane and laboratory values. Patients who are found to have low Na and K (Na <130 mEq/L, K <3.3mEq/L) or high in these parameters (Na ≥ 152 mEq/L, K ≥ 5.2 mEq/L) by laboratory tests at Visit 1. Patients with type I diabetes mellitus on treatment with insulin, or patients with type II diabetes with poor glucose control defined as a glycosylated hemoglobin (HbA1c) > 8.0% at Visit 1. Patients with or with a history of malignant tumors including leukemia and lymphoma, treated or untreated, within the past 5 years of Visit 1 whether or not there is evidence of local recurrence or metastases (except for localized basal cell carcinoma of the skin). Patients with any severe, life-threatening disease within the past 5 years. Patients with a history of autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. Any surgical or medical condition, which in the opinion of the investigator or subinvestigator, place the patient at higher risk from his/her participation in the study, or are likely to prevent the patient from complying with the requirement of the study or completing the trial period. Patients who have with or with a history of drug or alcohol abuse within the last 2 years of Visit 1. Patients who have received other investigational product within 12 weeks of Visit 1. Any chronic inflammatory condition needing chronic anti-inflammatory drug therapy. Persons directly involved in the execution of this study. Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or subinvestigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Japan
Organizational Affiliation
Sponsor GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Tokyo
ZIP/Postal Code
11111
Country
Japan

12. IPD Sharing Statement

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Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

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