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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
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
 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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1342
Study Start Date: October 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Aliskiren 150 mg
Aliskiren 150 mg 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: 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: 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
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: Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule
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
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: Aliskiren/Amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg tablet
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
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: Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg tablet
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237223

Locations
Japan
Investigative Site
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
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

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

Keywords provided by Novartis:
Aliskiren
Amlodipine
Essential hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 23, 2013