NCT00327587

Brief Summary

The purpose of this study is to determine the safety and efficacy of the various combinations of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,279

participants targeted

Target at P75+ for phase_3 hypertension

Timeline
Completed

Started May 2006

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

May 1, 2006

Completed
15 days 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
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

1.3 years

First QC Date

May 16, 2006

Last Update Submit

November 7, 2011

Conditions

Hypertension

Keywords

hypertensionvalsartanamlodipineHCTZ

Outcome Measures

Primary Outcomes (2)

  • Change from baseline diastolic blood pressure after 8 weeks

  • Change from baseline systolic blood pressure after 8 weeks

Secondary Outcomes (5)

  • Blood pressure less than 140/90 mmHg after 8 weeks

  • Systolic blood pressure less than 140 mmHg or diastolic blood pressure less than 90 mmHg after 8 weeks

  • Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease after 8 weeks or systolic blood pressure less than 140 mmHg or at least a 15 mmHg decrease after 8 weeks

  • Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements

  • Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 8 weeks

Interventions

Valsartan + amlodipineDRUG
Valsartan + HCTZDRUG
Amlodipine + HCTZDRUG
Valsartan + amlodipine + HCTZDRUG

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of moderate to severe hypertension (MSDBP ≥ 100 mmHg and \< 120 mmHg, MSSBP ≥ 145 mmHg and \< 200 mmHg).

You may not qualify if:

  • Patients on two or more antihypertensive drugs with MSSBP ≥ 180 mmHg and/or MSDBP ≥ 110 mmHg at Visit 1.
  • Patients on three or more antihypertensive drugs with MSDBP ≥ 90 mmHg and \< 110 mmHg, and/or MSSBP ≥ 140 mmHg and \< 180 mmHg at Visit 1.
  • Patients on four or more antihypertensive drugs at Visit 1.
  • Arm circumference \> 42 cm for patients participating in ABPM.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals Corporation

East Hanover, New Jersey, 07936, United States

Location

Related Publications (2)

  • Calhoun DA, Lacourciere Y, Crikelair N, Jia Y, Glazer RD. Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension. Curr Med Res Opin. 2013 Aug;29(8):901-10. doi: 10.1185/03007995.2013.803057. Epub 2013 Jul 1.

    PMID: 23721363DERIVED

  • Lacourciere Y, Crikelair N, Glazer RD, Yen J, Calhoun DA. 24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension. J Hum Hypertens. 2011 Oct;25(10):615-22. doi: 10.1038/jhh.2010.115. Epub 2011 Jan 20.

    PMID: 21248785DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Amlodipine, Valsartan Drug CombinationValsartanHydrochlorothiazideAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDihydropyridinesPyridinesValineAmino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialDrug CombinationsPharmaceutical PreparationsChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsOrganic ChemicalsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    PRINCIPAL INVESTIGATOR

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

May 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

US(1)