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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00344110
First received: June 22, 2006
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  Purpose

Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension


Condition Intervention Phase
Hypertension
 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:

U.S. FDA Resources

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)
  Eligibility

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

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00344110

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

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov 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:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013