NCT00327145

Brief Summary

This study is designed to provide additional efficacy and safety data for a treatment strategy based on the combination valsartan with amlodipine in hypertensive patients previously treated with monotherapy and remaining uncontrolled. A naturalistic approach will be taken comparing two different doses, i.e. 160mg of valsartan with amlodipine 5mg and 10mg with possible addition of HCTZ

Trial Health

87
On Track

Trial Health Score

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

Enrollment
894

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started Mar 2006

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

10 months

First QC Date

May 16, 2006

Last Update Submit

November 16, 2016

Conditions

Hypertension

Keywords

HCTZhypertensionvalsartanamlodipine

Outcome Measures

Primary Outcomes (1)

  • Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 16 weeks

Secondary Outcomes (4)

  • Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 8 weeks.

  • Blood pressure less than 140/90 mmHg in non diabetic patients or blood pressure less than 130/80 mmHg in diabetic patients after 4, 12, and 16 weeks.

  • Change from baseline diastolic and systolic blood pressure measurements after 4, 8, 12, and 16 weeks

  • Diastolic blood pressure less than 90 mmHg in non-diabetic patients and diastolic blood pressure less than 80 mmHg in diabetic patients after 4, 8, 12, and 16 weeks

Interventions

valsartanDRUG
hydrochlorothiazideDRUG
amlodipineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients ≥18 years of age
  • Non-diabetic patients must have MSSBP of ≥140 mmHg and/or MSDBP ≥90 mmHg at Visits 1 and 2. Diabetic patients must have MSSBP ≥130 mmHg and/or MSDBP ≥80 mmHg at Visits 1 and 2
  • Patients treated with monotherapy at a dose considered as adequate by the investigator for a minimum of two months prior to Visit 1

You may not qualify if:

  • Known or suspected contraindications, including history of allergy to ARBs, CCB, thiazides or to drugs with similar chemical structure.
  • MSSBP ≥180 mmHg and/or MSDBP ≥110 mmHg (MSSBP ≥160 mmHg and/or MSDBP ≥100 mmHg for diabetic patients) at any time between Visit 1 and Visit 2.
  • Evidence of a secondary form of hypertension, to include coarctation of the aorta, primary hyperaldosteronism, renal artery stenosis, or pheochromocytoma.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Basel, Switzerland

Location

Related Publications (1)

  • Allemann Y, Fraile B, Lambert M, Barbier M, Ferber P, Izzo JL Jr. Efficacy of the combination of amlodipine and valsartan in patients with hypertension uncontrolled with previous monotherapy: the Exforge in Failure after Single Therapy (EX-FAST) study. J Clin Hypertens (Greenwich). 2008 Mar;10(3):185-94. doi: 10.1111/j.1751-7176.2008.07516.x.

    PMID: 18326958RESULT

MeSH Terms

Conditions

Hypertension

Interventions

ValsartanHydrochlorothiazideAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDihydropyridinesPyridines

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 18, 2006

Study Start

March 1, 2006

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations

CH(1)