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

May 11, 2012 updated by: Novartis

An 8-week Double-blind, Multicenter, Randomized, 6-arm, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren and Amlodipine) in Patients With Essential Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1342

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Investigative Site
      • Ehime, Japan
        • Investigative Site
      • Fukuoka, Japan
        • Investigative Site
      • Hokkaido, Japan
        • Investigative Site
      • Hyogo, Japan
        • Investigative Site
      • Kanagawa, Japan
        • Investigative Site
      • Kyoto, Japan
        • Investigative Site
      • Okayama, Japan
        • Investigative Site
      • Osaka, Japan
        • Investigative Site
      • Saitama, Japan
        • Investigative Site
      • Tokyo, Japan
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with essential hypertension (msDBP ≥ 95 mmHg and < 110 mmHg and msSBP ≥140 mmHg )
  • Outpatients

Exclusion Criteria:

  • Severe hypertension (msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
  • History of allergy or hypersensitivity to renin inhibitors, calcium channel blockers
  • History or evidence of a secondary hypertension

Other protocol-defined inclusion/exclusion criteria applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
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
ACTIVE_COMPARATOR: Aliskiren 150 mg

In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
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
Drug: Aliskiren 150 mg
Aliskiren 150 mg tablet
ACTIVE_COMPARATOR: Amlodipine 2.5 mg

In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period.
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
Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule
ACTIVE_COMPARATOR: Amlodipine 5 mg

In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
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
Drug: Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule
EXPERIMENTAL: Aliskiren/amlodipine 150/2.5 mg

In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period.
Drug: Placebo of Aliskiren
Aliskiren placebo tablet
Drug: Placebo of Amlodipine
Amlodipine placebo capsule
Drug: Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet
Drug: Aliskiren/Amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg tablet
EXPERIMENTAL: Aliskiren/amlodipine 150/5 mg

In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.

Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period.
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: Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
Time Frame: Baseline, Week 8
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Baseline, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
Time Frame: Baseline, Week 8
Sitting blood pressure was measured at trough (24 hours ± 2 hours post dose) and recorded at all study visits. At the first study visit, blood pressure was measured in both arms and the arm with highest sitting DBP was found and used for all subsequent readings throughout the study. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these three sitting blood pressure measurements were used as the average sitting blood pressure for that visit. Analysis of covariance (ANCOVA) model contained treatment and region as two factors and baseline as a covariate.
Baseline, Week 8
Percentage of Participants Achieving Blood Pressure Control at Endpoint
Time Frame: 8 weeks
Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.
8 weeks
Percentage of Participants Achieving a Successful Response Rate
Time Frame: 8 weeks
The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
8 weeks
Number of Participants With Adverse Events, Serious Adverse Events and Death
Time Frame: 8 weeks
Number of patients with adverse events regardless of study drug relationship during the double-blind treatment period were reported. Serious adverse events of double blind period were reported.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

October 29, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (ESTIMATE)

November 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2012

Last Update Submitted That Met QC Criteria

May 11, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPA100A1301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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