NCT00446524

Brief Summary

The purpose of this study is to evaluate long-term safety and tolerability of once daily administration of the combination of Valsartan and Amlodipine 80/5 mg for 52 weeks in patients with essential hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
403

participants targeted

Target at P50-P75 for phase_3 hypertension

Timeline
Completed

Started Feb 2007

Typical duration for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

March 9, 2007

Last Update Submit

March 24, 2017

Conditions

Hypertension

Keywords

Hypertension, Valsartan, Amlodipine, high blood pressure

Outcome Measures

Primary Outcomes (1)

  • Safety assessed by serious and non-serious adverse events

    No new unexpected AE's were observed in long-term treatment with VAA 80/5 mg. There were no deaths during the study. The SAEs were rare, with 9 patients (2.5%) reporting 10 events (1 patient experienced 2 SAEs). These events were not clustered to any particular primary system organ class and only 2 events the investigators could not excluded a relationship to study drug. The events that occurred were expected in this study population and/or were known to be associated with either valsartan or amlodipine. AEs leading to discontinuation occurred in 14 patients (3.8%).

    12 months

Secondary Outcomes (4)

  • Efficacy assessed by the changes-from baseline measurements in mean sitting diastolic blood pressure, mean sitting systolic blood pressure, standing diastolic blood pressure, and standing systolic blood pressure

    12 months

  • Laboratory tests

    12 months

  • Vital signs

    12 months

  • Electrocardiogram (ECG)

    12 months

Study Arms (2)

Valsartan + Amlodipine 80/5 mg

EXPERIMENTAL

Valsartan 80 mg or Amlodipine 5 mg ---\> Valsartan + Amlodipine 80 / 5 mg

Drug: Valsartan + Amlodipine besilate

Valsartan + Amlodipine 80/5 mg + Diuretic

EXPERIMENTAL

Valsartan + Amlodipine 80 / 5 mg + Diuretic

Drug: Valsartan + Amlodipine besilate

Interventions

Valsartan + Amlodipine besilateDRUG

During the run-in period, either Valsartan 80 mg or Amlodipine 5 mg tablet was given once daily. Throughout the Valsartan + Amlodipine treatment period, a Valsartan + Amlodipine tablet 80/5 mg was given once daily at around 8:00 AM in the morning.

Also known as: Valsartan, Amlodipine besilate, VAL, AML
Valsartan + Amlodipine 80/5 mgValsartan + Amlodipine 80/5 mg + Diuretic

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who successfully complete the core study (Study CVAA489A1301.
  • Patients whose blood pressure at Visit 7 of the Study CVAA489A1301 had to be well controlled defined as MSDBP \< 90 mmHg and MSSBP \< 140 mmHg. At the investigator's or sub-investigator's discretion, those patients who were not well controlled (MSDBP ≥ 90 mmHg or MSSBP ≥ 140 mmHg), and whose MSDBP was \< 100 mmHg and MSSBP was \< 160 mmHg might participate in the extension if this was considered an acceptable level of blood pressure control for the patient.
  • Male or female outpatients.
  • Patients who have written informed consent to participate in this study.

You may not qualify if:

  • Presence of major protocol violation in Study CVAA489A1301.
  • Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
  • Patients who experienced any adverse events considered serious and drug related in Study CVAA489A1301.
  • Patients who are considered unlikely to comply with the requirements specified in the protocol by the investigator or sub-investigator.
  • Patients who have gout or gouty arthritis.
  • Patients hypersensitive to diuretics (except for potassium sparing diuretics).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Fukuoka, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanAmlodipineValine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDihydropyridinesPyridines

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 13, 2007

Study Start

February 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

JP(1)