Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg in Patients With Mild to Moderate Essential Hypertension

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: June 22, 2006
Last updated: November 7, 2011
Last verified: November 2011
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Condition Intervention Phase
Drug: Aliskiren
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo and Active-controlled, Multicenter, Parallel-group Study Comparing SPP100 (Aliskiren) 150mg to Placebo and to Losartan 50mg to Evaluate Efficacy, Safety and Pharmacokinetics in Patients With Mild to Moderate Essential Hypertension

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean sitting diastolic blood pressure (msDBP) lowering from baseline to the study end to placebo and losartan

Secondary Outcome Measures:
  • Mean sitting systolic pressure (msSBP) lowering from baseline to the study end to placebo and losartan
  • Successful response; msDBP <90mmHg and/or a reduction of msDBP ≥ 10mmHg
  • Control rate; msDBP <90mmHg and msSBP<140mmHg
  • The pharmacokinetics / pharmacodynamics
  • Safety and tolerability

Enrollment: 768
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Age: 20 - 75 years old
  • Gender: Male or female
  • Status: Outpatients
  • Mild to moderate essential hypertension

Exclusion Criteria:

  • Pregnant women, lactating mothers, women suspected of being pregnant, or women who wish to be pregnant
  • Patients with msSBP >==180 mmHg and/or msDBP >=110 mmHg at Visit 1, 2 or 3
  • Patients with or suspected of having secondary hypertension (due to aortic coarctation, primary aldosteronism, etc.)
  • Patients suspected of having malignant hypertension

Other protocol-defined inclusion/exclusion criteria may apply

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Please refer to this study by its identifier: NCT00344110

Novartis Pharmaceuticals
Japan, Japan
Sponsors and Collaborators
Study Chair: Novartis Pharmaceuticals, Japan Novartis Pharmaceuticals, Japan
  More Information

No publications provided

Responsible Party: Novartis Identifier: NCT00344110     History of Changes
Other Study ID Numbers: CSPP100A1301 
Study First Received: June 22, 2006
Last Updated: November 7, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:
Hypertension, aliskiren, blood pressure, renin

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases processed this record on February 04, 2016