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CompletedNCT00246584Updated Jul 28, 2006

A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)

A Phase 2 interventional study of SPP100 in Hypertension, sponsored by Novartis. Completed at 1 site in Switzerland. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2006-07-28.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)

02

Conditions studied

  • Hypertension

Keywords

  • Hypertension
  • angiotensin
  • renin
  • aliskiren
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 300 is above the median of 90 across 4,995 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
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed as essential hypertension -

Exclusion criteria

Exclusion Criteria:

  • Patients with secondary hypertension or suspected of having secondary hypertension.
  • Patients suspected of having malignant hypertension
  • Patients with any serious diseases or symptoms
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants

Interventions

  • DrugSPP100
06

What researchers measure

Primary outcomes

  1. Incidence of adverse events, vital signs, abnormal laboratory changes,etc.

Secondary outcomes

  1. Change from baseline in diastolic blood pressure after 52 weeks

  2. Change from baseline in systolic blood pressure after 52 weeks

  3. Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks

07

Study locations

1 site
  • Novartis Pharmaceuticals
    Basel, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00246584
Lead sponsor
Novartis
First posted
Oct 30, 2005
Start date
Oct 2004
Last update
Jul 28, 2006

Study contacts

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

Not currently enrolling

This study is completed, as verified in Jul 2006. You cannot join it, but the record below documents what was studied.

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