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Completed

NCT Number: NCT01237223

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

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aliskiren/Amlodipine 150/2.5 mg

Drug

Aliskiren/amlodipine 150/2.5 mg tablet

Aliskiren/amlodipine 150/5 mg

Drug

Aliskiren/amlodipine 150/5 mg tablet

Aliskiren 150 mg

Drug

Aliskiren 150 mg tablet

Amlodipine 2.5 mg

Drug

Amlodipine 2.5 mg capsule

Placebo of Aliskiren

Drug

Aliskiren placebo tablet

Placebo of Amlodipine

Drug

Amlodipine placebo capsule

Placebo of Aliskiren/amlodipine 150/2.5 mg

Drug

Aliskiren/amlodipine 150/2.5 mg placebo tablet

Placebo of Aliskiren/amlodipine 150/5 mg

Drug

Aliskiren/amlodipine 150/5 mg placebo tablet

Primary outcomes

  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) to End of Study (Week 8)

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline, 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.

  2. Percentage of Participants Achieving Blood Pressure Control at Endpoint

    Time frame: 8 weeks

    Blood pressure control is defined as having as a msDBP < 90 mmHg and a msSBP < 140 mmHg.

  3. Percentage of Participants Achieving a Successful Response Rate

    Time frame: 8 weeks

    The response rate was defined as percentage of participants who achieved msDBP < 90 mmHg or its reduction ≥ 10 mmHg from baseline to endpoint.

  4. Number of Participants With Adverse Events, Serious Adverse Events and Death

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 9, 2010
Registry last updated
Jun 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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