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Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension

NCT01237223 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1342

Last updated 2012-06-13

Study results available
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Summary

The purpose of the study was to evaluate the efficacy (blood pressure lowering effect) and safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in patients with essential hypertension (mean sitting diastolic blood pressure \[msDBP\] ≥ 95 mmHg and \< 110 mmHg and mean sitting systolic blood pressure \[msSBP\] ≥ 140 mmHg ). This study was conducted to support registration of the fixed-dose combination of aliskiren and amlodipine for the treatment of hypertension in Japan.

Conditions

  • Essential Hypertension

Interventions

DRUG

Aliskiren/Amlodipine 150/2.5 mg

Aliskiren/amlodipine 150/2.5 mg tablet

DRUG

Aliskiren/amlodipine 150/5 mg

Aliskiren/amlodipine 150/5 mg tablet

DRUG

Aliskiren 150 mg

Aliskiren 150 mg tablet

DRUG

Amlodipine 2.5 mg

Amlodipine 2.5 mg capsule

DRUG

Placebo of Aliskiren

Aliskiren placebo tablet

DRUG

Placebo of Amlodipine

Amlodipine placebo capsule

DRUG

Placebo of Aliskiren/amlodipine 150/2.5 mg

Aliskiren/amlodipine 150/2.5 mg placebo tablet

DRUG

Placebo of Aliskiren/amlodipine 150/5 mg

Aliskiren/amlodipine 150/5 mg placebo tablet

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237223 on ClinicalTrials.gov