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Completed

NCT Number: NCT00246584

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

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)

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Pharmaceuticals

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as essential hypertension -

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

Treatment and study plan

SPP100

Drug

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Long-Term Treatment, Multicenter, Open-Label Study With SPP100 in Patients With Essential Hypertension

Important dates

Study start
2004
First posted
Oct 31, 2005
Registry last updated
Jul 28, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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