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

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ClinicalTrials.gov Identifier: NCT00344110
Recruitment Status : Completed
First Posted : June 26, 2006
Last Update Posted : November 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Assessing efficacy, safety and pharmacokinetics in patients with mild to moderate essential hypertension

Condition or disease Intervention/treatment Phase
Hypertension Drug: Aliskiren Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : June 2006
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00344110


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

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00344110     History of Changes
Other Study ID Numbers: CSPP100A1301
First Posted: June 26, 2006    Key Record Dates
Last Update Posted: November 18, 2016
Last Verified: November 2016

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action