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

Essential Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01237223
• Other study ID #: CSPA100A1301
• Status: Completed
• Phase: Phase 3
• First received: October 29, 2010
• Last updated: May 11, 2012
• Start date: October 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1342
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Aliskiren/Amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg tablet
• Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg tablet
• Aliskiren 150 mg
Aliskiren 150 mg tablet
• Amlodipine 2.5 mg
Amlodipine 2.5 mg capsule
• Placebo of Aliskiren
Aliskiren placebo tablet
• Placebo of Amlodipine
Amlodipine placebo capsule
• Placebo of Aliskiren/amlodipine 150/2.5 mg
Aliskiren/amlodipine 150/2.5 mg placebo tablet
• Placebo of Aliskiren/amlodipine 150/5 mg
Aliskiren/amlodipine 150/5 mg placebo tablet

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Week 8	No
Secondary	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.	Baseline, Week 8	No
Secondary	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.	8 weeks	No
Secondary	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.	8 weeks	No
Secondary	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.	8 weeks	Yes