Back to resultsEfficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Aliskiren/Amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/5 mg
Aliskiren 150 mg
Amlodipine 2.5 mg
Placebo of Aliskiren
Placebo of Amlodipine
Placebo of Aliskiren/amlodipine 150/2.5 mg
Placebo of Aliskiren/amlodipine 150/5 mg
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension focused on measuring Aliskiren, Amlodipine, Essential hypertension
Eligibility Criteria
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
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
- Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Experimental
Experimental
Arm Label
Placebo
Aliskiren 150 mg
Amlodipine 2.5 mg
Amlodipine 5 mg
Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/5 mg
Arm Description
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (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.
Secondary Outcome Measures
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (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.
Percentage of Participants Achieving Blood Pressure Control at Endpoint
Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.
Percentage of Participants Achieving a Successful Response Rate
The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
Number of Participants With Adverse Events, Serious Adverse Events and Death
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01237223
Brief Title
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Aliskiren, Amlodipine, Essential hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1342 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Aliskiren 150 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Amlodipine 2.5 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Amlodipine 5 mg
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aliskiren/amlodipine 150/2.5 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Aliskiren/amlodipine 150/5 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aliskiren/Amlodipine 150/2.5 mg
Intervention Description
Aliskiren/amlodipine 150/2.5 mg tablet
Intervention Type
Drug
Intervention Name(s)
Aliskiren/amlodipine 150/5 mg
Intervention Description
Aliskiren/amlodipine 150/5 mg tablet
Intervention Type
Drug
Intervention Name(s)
Aliskiren 150 mg
Intervention Description
Aliskiren 150 mg tablet
Intervention Type
Drug
Intervention Name(s)
Amlodipine 2.5 mg
Intervention Description
Amlodipine 2.5 mg capsule
Intervention Type
Drug
Intervention Name(s)
Placebo of Aliskiren
Intervention Description
Aliskiren placebo tablet
Intervention Type
Drug
Intervention Name(s)
Placebo of Amlodipine
Intervention Description
Amlodipine placebo capsule
Intervention Type
Drug
Intervention Name(s)
Placebo of Aliskiren/amlodipine 150/2.5 mg
Intervention Description
Aliskiren/amlodipine 150/2.5 mg placebo tablet
Intervention Type
Drug
Intervention Name(s)
Placebo of Aliskiren/amlodipine 150/5 mg
Intervention Description
Aliskiren/amlodipine 150/5 mg placebo tablet
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)
Description
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.
Time Frame
Baseline, Week 8
Title
Percentage of Participants Achieving Blood Pressure Control at Endpoint
Description
Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.
Time Frame
8 weeks
Title
Percentage of Participants Achieving a Successful Response Rate
Description
The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.
Time Frame
8 weeks
Title
Number of Participants With Adverse Events, Serious Adverse Events and Death
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Aichi
Country
Japan
Facility Name
Investigative Site
City
Ehime
Country
Japan
Facility Name
Investigative Site
City
Fukuoka
Country
Japan
Facility Name
Investigative Site
City
Hokkaido
Country
Japan
Facility Name
Investigative Site
City
Hyogo
Country
Japan
Facility Name
Investigative Site
City
Kanagawa
Country
Japan
Facility Name
Investigative Site
City
Kyoto
Country
Japan
Facility Name
Investigative Site
City
Okayama
Country
Japan
Facility Name
Investigative Site
City
Osaka
Country
Japan
Facility Name
Investigative Site
City
Saitama
Country
Japan
Facility Name
Investigative Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of SPA100 (Fixed-dose Combination of Aliskiren/Amlodipine) in Patients With Essential Hypertension
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