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

NCT01237223 | Completed Phase 3 Results

• 1 other identifier: CSPA100A1301
• Study Type: interventional
• Target: 1,342
• Locations: 1 country
• Sites: 11

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.

Conditions

Essential Hypertension

Keywords

Aliskiren; Amlodipine; Essential hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) to End of Study (Week 8)

  Baseline, Week 8

• Percentage of Participants Achieving Blood Pressure Control at Endpoint

  8 weeks

• Percentage of Participants Achieving a Successful Response Rate

  8 weeks

• Number of Participants With Adverse Events, Serious Adverse Events and Death

  8 weeks

Study Arms (6)

Placebo

PLACEBO COMPARATOR

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; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Aliskiren 150 mg

ACTIVE COMPARATOR

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; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Amlodipine 2.5 mg

ACTIVE COMPARATOR

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; 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

Amlodipine 5 mg

ACTIVE COMPARATOR

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; Drug: Placebo of Aliskiren; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg; Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Aliskiren/amlodipine 150/2.5 mg

EXPERIMENTAL

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; Drug: Placebo of Aliskiren; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/5 mg

Aliskiren/amlodipine 150/5 mg

EXPERIMENTAL

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; Drug: Placebo of Aliskiren; Drug: Placebo of Amlodipine; Drug: Placebo of Aliskiren/amlodipine 150/2.5 mg

Interventions

Aliskiren/Amlodipine 150/2.5 mg DRUG

Aliskiren/amlodipine 150/2.5 mg tablet

Aliskiren/amlodipine 150/2.5 mg

Aliskiren/amlodipine 150/5 mg DRUG

Aliskiren/amlodipine 150/5 mg tablet

Aliskiren/amlodipine 150/5 mg

Aliskiren 150 mg DRUG

Aliskiren 150 mg tablet

Aliskiren 150 mg

Amlodipine 2.5 mg DRUG

Amlodipine 2.5 mg capsule

Amlodipine 2.5 mg; Amlodipine 5 mg

Placebo of Aliskiren DRUG

Aliskiren placebo tablet

Aliskiren/amlodipine 150/2.5 mg; Aliskiren/amlodipine 150/5 mg; Amlodipine 2.5 mg; Amlodipine 5 mg; Placebo

Placebo of Amlodipine DRUG

Amlodipine placebo capsule

Aliskiren 150 mg; Aliskiren/amlodipine 150/2.5 mg; Aliskiren/amlodipine 150/5 mg; Amlodipine 2.5 mg; Placebo

Placebo of Aliskiren/amlodipine 150/2.5 mg DRUG

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Aliskiren 150 mg; Aliskiren/amlodipine 150/5 mg; Amlodipine 2.5 mg; Amlodipine 5 mg; Placebo

Placebo of Aliskiren/amlodipine 150/5 mg DRUG

Aliskiren/amlodipine 150/5 mg placebo tablet

Aliskiren 150 mg; Aliskiren/amlodipine 150/2.5 mg; Amlodipine 2.5 mg; Amlodipine 5 mg; Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

Study Sites (11)

Investigative Site

Aichi, Japan

Location

Investigative Site

Ehime, Japan

Location

Investigative Site

Fukuoka, Japan

Location

Investigative Site

Hokkaido, Japan

Location

Investigative Site

Hyōgo, Japan

Location

Investigative Site

Kanagawa, Japan

Location

Investigative Site

Kyoto, Japan

Location

Investigative Site

Okayama, Japan

Location

Investigative Site

Osaka, Japan

Location

Investigative Site

Saitama, Japan

Location

Investigative Site

Tokyo, Japan

Location

MeSH Terms

Conditions

Essential Hypertension

Interventions

aliskiren; Amlodipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 13, 2012
• Results First Posted: June 13, 2012

Record last verified: 2012-05

Locations

JP (11)