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CompletedNCT00280540Updated Nov 9, 2010

Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

A Phase 4 interventional study of Valsartan/Hydrochlorothiazide in Hypertension, sponsored by Novartis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-09.

Sponsored by Novartis · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
648
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

02

Conditions studied

  • Hypertension

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Keywords

  • Hypertension
  • High blood pressure
  • Blood pressure control
  • Blood pressure reduction
  • Valsartan
03

In context

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's enrollment of 648 is above the median of 90 across 4,996 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 and older
Sexes eligible
All

Inclusion criteria

  • Male or female age 18 or older
  • Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but \< 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and \<110 mm Hg)

Exclusion criteria

Exclusion Criteria:

  • Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
  • History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
  • History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
648 participants

Interventions

  • DrugValsartan/Hydrochlorothiazide
06

What researchers measure

Primary outcomes

  1. Change from baseline systolic blood pressure after 4 weeks

  2. Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary outcomes

  1. Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period

  2. Blood pressure less than 140/90 mmHg after 6 weeks

  3. Change from baseline diastolic blood pressure after 6 weeks

  4. Change from baseline in blood and urine markers after 6 weeks

07

Study locations

1 site
  • Novartis Pharmaceuticals
    East Hanover, New Jersey 07936, United States
08

References and documents

Publications

  • Zappe DH, Palmer BF, Calhoun DA, Purkayastha D, Samuel R, Jamerson KA. Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension. J Hum Hypertens. 2010 Jul;24(7):483-91. doi: 10.1038/jhh.2009.90. Epub 2009 Dec 10. PubMed 20010618 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00280540
Lead sponsor
Novartis
First posted
Jan 23, 2006
Start date
Dec 2005
Primary completion
Aug 2006
Last update
Nov 9, 2010

Study contacts

Novartis Pharmaceuticals
study director · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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