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

This study has been completed.

First Received on June 22, 2006. Last Updated on November 7, 2011 History of Changes

Sponsor:	Novartis
Information provided by (Responsible Party):	Novartis
ClinicalTrials.gov Identifier:	NCT00344110

Purpose

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

Condition	Intervention	Phase
Hypertension	Drug: Aliskiren	Phase III

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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Losartan Losartan potassium Aliskiren

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

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 February 09, 2012