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CompletedNCT00548067Updated Sep 27, 2010

Pharmacokinetic Drug Interaction Study Following Co-administration of Valsartan, Hydrochlorothiazide and Amlodipine in Patients With Hypertension

A Phase 3 interventional study of Valsartan/hydrochlorothiazide (HCTZ) and Valsartan/amlodipine in Hypertension, sponsored by Novartis. Completed at 5 sites in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-09-27.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.

02

Conditions studied

  • Hypertension

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Keywords

  • High blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 111 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.

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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 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients diagnosed as hypertensive
  • Untreated confirmed hypertensive patients (consistent SBP >140 mm Hg or DBP >90 mm Hg)
  • Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on one drug therapy.
  • Uncontrolled hypertensive patients (Consistent SBP >140 mm Hg or DBP >90 mm Hg) on two drug therapy.

Exclusion criteria

Exclusion Criteria:

  • Inability to switch from all prior antihypertensive medications safely as required by the protocol.
  • Need for drugs other than study drugs at the time of baseline.
  • Patients with SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at screening.
  • Patients on four or more antihypertensive drugs at screening.
  • Pregnant or nursing (lactating) women.
  • Patients with diabetes mellitus
  • Patients with heart diseases and any other disease

Other protocol-defined inclusion/exclusion criteria may apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants (actual)

Study arms

  • Active comparator
    1

    Drug: Valsartan/hydrochlorothiazide (HCTZ)

  • Active comparator
    2

    Drug: Valsartan/amlodipine

  • Active comparator
    3

    Drug: Amlodipine/hydrochlorothiazide(HCTZ)

  • Experimental
    4

    Drug: Valsartan/amlodipine/hydrochlorothiazide(HCTZ)

Interventions

  • DrugValsartan/hydrochlorothiazide (HCTZ)
  • DrugValsartan/amlodipine
  • DrugAmlodipine/hydrochlorothiazide(HCTZ)
  • DrugValsartan/amlodipine/hydrochlorothiazide(HCTZ)
06

What researchers measure

Primary outcomes

  1. Potential drug interaction and effect on blood level of drugs when co-administered for 17 days

Secondary outcomes

  1. Safety and tolerability of co-administered assessed by capturing adverse events and safety laboratory

07

Study locations

5 sites
  • Novartis Investigative Site
    Ahmedabad, India
  • Novartis investigative site
    Bangalore, India
  • Novartis Investigative site
    Hyderabad, India
  • Novartis Investigative site
    Mangalore, India
  • Novartis investigative site
    Mehasana, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00548067
Lead sponsor
Novartis
First posted
Oct 23, 2007
Start date
Sep 2007
Completion
Mar 2008
Last update
Sep 27, 2010

Study contacts

Novartis
principal investigator · Novartis investigative site

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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