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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01237223
Other study ID # CSPA100A1301
Secondary ID
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


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
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