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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00344110
• Collaborator: (none)
• Enrollment: 768
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 76.9

Study Details

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
• 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: Jun 1, 2006
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Apr 1, 2007

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

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	Japan		Japan

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis Pharmaceuticals, Japan, Novartis Pharmaceuticals, Japan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT00344110
• Other Study ID Numbers: CSPP100A1301
• First Posted: Jun 26, 2006
• Last Update Posted: Nov 18, 2016
• Last Verified: Nov 1, 2016

• Keywords provided by Novartis: Hypertension, aliskiren, blood pressure, renin
• Additional relevant MeSH terms: Hypertension; Essential Hypertension

Study Results

No Results Posted as of Nov 18, 2016