To Demonstrate Non-inferiority of Combination of 5 mg Amlodipine/ 80 mg Valsartan to 160 mg Valsartan Alone

NCT01070043 | Completed Phase 4 Results

• 1 other identifier: CVAA489ATW01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.

Conditions

Hypertension; High Blood Pressure

Keywords

Hypertension; valsartan; amlodipine; high blood pressure

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) From Office Blood Pressure Measurement

  Two 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 mean sitting systolic blood pressure (msSBP) was calculated comparing the Week 8 readings to the readings taken at baseline.

  Baseline and 8 weeks

• Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) From Office Blood Pressure Measurement

  Two 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 mean sitting diastolic blood pressure (msDBP) was calculated comparing the Week 8 readings to the readings taken at Baseline.

  Baseline and 8 weeks

Secondary Outcomes (3)

• Change From Baseline in Mean Systolic Blood Pressure (mSBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours

  Baseline and 8 weeks

• Change From Baseline in Mean Diastolic Blood Pressure (mDBP) From Ambulatory Blood Pressure Measurement (ABPM) Over 24 Hours After 8 Weeks of Treatment During the Double-blind Phase

  Baseline and 8 weeks

• Number of Participants With Adverse Events During Double-blind Phase

  8 weeks

Study Arms (3)

Amlodipine 5mg/Valsartan 80 mg

EXPERIMENTAL

During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.

Drug: Amlodipine 5mg/Valsartan 80 mg

Valsartan 160 mg

ACTIVE COMPARATOR

In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.

Drug: Valsartan

Run-In Valsartan 80 mg

OTHER

During run-in period, oral valsartan 80 mg once daily for 4 weeks.

Drug: Valsartan

Interventions

Amlodipine 5mg/Valsartan 80 mg DRUG

Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.

Also known as: Exforge

Amlodipine 5mg/Valsartan 80 mg

Valsartan DRUG

For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks. Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks

Also known as: Diovan

Run-In Valsartan 80 mg; Valsartan 160 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants over 18 years of age with hypertension defined as sitting systolic blood pressure between 140 mmHg and 180 mmHg or sitting diastolic blood pressure between 90 mmHg and 120 mmHg.
• High risk participants ( defined as having: (diabetes mellitus, chronic renal disease, Framingham 10-year risk score \>10%, established coronary artery disease (CAD), or CAD equivalents including carotid artery disease, peripheral arterial disease (PAD), abdominal aortic aneurysm (AAA))with hypertension defined as sitting systolic blood pressure between 130 mmHg and 180 mmHg or sitting diastolic blood pressure between 80 mmHg and 120 mmHg.

You may not qualify if:

• Known or suspected secondary hypertension
• Known New York Heart Association (NYHA) functional class IV Heart Failure
• History of myocardial infarction, transient ischemic attack or cerebrovascular accident within the preceding 3 months
• Clinically significant valvular disease
• Women who are pregnant, intend to become pregnant or are breastfeeding
• Participants who have severe medical condition(s) that in the view of the Investigator prohibits participation in the study
• Participants who have hypersensitivity to the investigational/ reference drug or any of the components in the formulation.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Unknown Facility

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 - 778- 8300

Study Officials

• Novartis Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2010
• First Posted: February 17, 2010
• Study Start: June 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 19, 2011
• Results First Posted: October 19, 2011

Record last verified: 2011-09

Locations

TW (1)