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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT01237223

First received: October 29, 2010

Last updated: May 11, 2012

Last verified: May 2012

History of Changes

Results First Received: May 11, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Essential Hypertension
Interventions:	Drug: Aliskiren/Amlodipine 150/2.5 mg Drug: Aliskiren/amlodipine 150/5 mg Drug: Aliskiren 150 mg Drug: Amlodipine 2.5 mg Drug: Placebo of Aliskiren Drug: Placebo of Amlodipine Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.
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.
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.
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.
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.
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.

Participant Flow for 2 periods

Period 1: Single Blind(Run-in Period, 4 Weeks)

	Placebo	Aliskiren 150 mg	Amlodipine 2.5 mg	Amlodipine 5 mg	Aliskiren/Amlodipine 150/2.5 mg	Aliskiren/Amlodipine 150/5 mg
STARTED	1342 ^[1]	0	0	0	0	0
COMPLETED	944	0	0	0	0	0
NOT COMPLETED	398	0	0	0	0	0
Adverse Event	29	0	0	0	0	0
Abnormal laboratory value(s)	25	0	0	0	0	0
Abnormal test procedure result(s)	308	0	0	0	0	0
Subject withdrew consent	28	0	0	0	0	0
Protocol deviation(s)	8	0	0	0	0	0

[1]	All the patients enrolled to single blind period received only placebo treatment.

Period 2: Double Blind (Treatment Period, 8 Weeks)

	Placebo	Aliskiren 150 mg	Amlodipine 2.5 mg	Amlodipine 5 mg	Aliskiren/Amlodipine 150/2.5 mg	Aliskiren/Amlodipine 150/5 mg
STARTED	153	157	158	158	159	159
COMPLETED	120	142	143	153	155	154
NOT COMPLETED	33	15	15	5	4	5
Adverse Event	12	4	3	2	2	1
Unsatisfactory therapeutic effect	20	6	7	1	0	1
Withdrawal by Subject	1	4	4	0	1	1
Administrative problems	0	0	0	0	0	1
Protocol deviation(s)	0	1	1	2	1	1

Baseline Characteristics

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Reporting Groups

	Description
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. 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 for 8 weeks of double blind period.
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.
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.
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.
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.
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.
Total	Total of all reporting groups

Baseline Measures

	Placebo	Aliskiren 150 mg	Amlodipine 2.5 mg	Amlodipine 5 mg	Aliskiren/Amlodipine 150/2.5 mg	Aliskiren/Amlodipine 150/5 mg	Total
Number of Participants [units: participants]	153	157	158	158	159	159	944
Age ^[1] [units: years] Mean ± Standard Deviation	54.6 ± 8.35	55.0 ± 9.96	54.8 ± 10.25	55.8 ± 10.05	54.6 ± 11.11	55.5 ± 9.86	55.1 ± 9.96
Age, Customized [units: participants]
< 65 years	128	131	129	126	125	127	766
>=65 years	25	26	29	32	34	32	178
Gender [units: participants]
Female	45	39	45	51	51	57	288
Male	108	118	113	107	108	102	656

[1]	Baseline measurements were based on randomized patients.

Outcome Measures

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1. Primary:

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) [ Time Frame: Baseline, Week 8 ]

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2. Secondary:

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8) [ Time Frame: Baseline, Week 8 ]

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3. Secondary:

Percentage of Participants Achieving Blood Pressure Control at Endpoint [ Time Frame: 8 weeks ]

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4. Secondary:

Percentage of Participants Achieving a Successful Response Rate [ Time Frame: 8 weeks ]

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Measure Type	Secondary
Measure Title	Percentage of Participants Achieving a Successful Response Rate
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Full analysis set (FAS) included all randomized patients received at least one dose of double-blind study medication

Reporting Groups

	Description
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. 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 for 8 weeks of double blind period.
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.
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.
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.
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.
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.

Measured Values

	Placebo	Aliskiren 150 mg	Amlodipine 2.5 mg	Amlodipine 5 mg	Aliskiren/Amlodipine 150/2.5 mg	Aliskiren/Amlodipine 150/5 mg
Number of Participants Analyzed [units: participants]	153	157	158	158	159	159
Percentage of Participants Achieving a Successful Response Rate [units: percentage of participants]	34.6	46.5	50.6	70.3	65.4	86.2

No statistical analysis provided for Percentage of Participants Achieving a Successful Response Rate

5. Secondary:

Number of Participants With Adverse Events, Serious Adverse Events and Death [ Time Frame: 8 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01237223 History of Changes
Other Study ID Numbers:	CSPA100A1301
Study First Received:	October 29, 2010
Results First Received:	May 11, 2012
Last Updated:	May 11, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

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