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CompletedNCT00327587Updated Nov 8, 2011

8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension

A Phase 3 interventional study of Valsartan + amlodipine and Valsartan + HCTZ in Hypertension, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-11-08.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,279
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension

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Keywords

  • hypertension
  • valsartan
  • amlodipine
  • HCTZ
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's enrollment of 2,279 is above the median of 90 across 4,994 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.

Other protocol-defined exclusion criteria may apply.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
2,279 participants (actual)

Interventions

  • DrugValsartan + amlodipine
  • DrugValsartan + HCTZ
  • DrugAmlodipine + HCTZ
  • DrugValsartan + amlodipine + HCTZ
06

What researchers measure

Primary outcomes

  1. Change from baseline diastolic blood pressure after 8 weeks

  2. Change from baseline systolic blood pressure after 8 weeks

Secondary outcomes

  1. Blood pressure less than 140/90 mmHg after 8 weeks

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

  3. 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

  4. Ambulatory blood pressure and standing systolic and diastolic blood pressure measurements

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

07

Study locations

1 site
  • Novartis Pharmaceuticals Corporation
    E. Hanover, New Jersey 07936, United States
08

References and documents

Publications

  • 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. PubMed 23721363 ↗
  • 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. PubMed 21248785 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00327587
Lead sponsor
Novartis
Responsible party
Sponsor
First posted
May 18, 2006
Start date
May 2006
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Nov 8, 2011

Study contacts

Novartis Pharmaceuticals
principal investigator · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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