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Completed

NCT Number: NCT00311012

SPP100 Dose Finding Study in Japan

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.

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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

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Mild to moderate essential hypertension
  • Age: ≥20 years old and <80 years old (at time informed consent obtained)
  • Sex: N/A
  • Admission status: Outpatient

Exclusion criteria

  • Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
  • Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
  • Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
  • Patients suspected of having malignant hypertension

Treatment and study plan

Aliskiren

Drug

Primary outcomes

  1. Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary outcomes

  1. Change from baseline in mean sitting systolic blood pressure after 8 weeks

  2. Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks

  3. Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Dose-finding Study of SPP100 in Essential Hypertension

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 5, 2006
Registry last updated
Nov 8, 2011

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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