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Completed

NCT Number: NCT00797862

Aliskiren and the Calcium Channel Blocker Amlodipine Combination as an Initial Treatment Strategy for Hypertension

This study will compare the safety and efficacy of initial combination treatment with aliskiren + amlodipine to sequential add-on treatment strategies with aliskiren or amlodipine in patients with hypertension.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Toronto, Canada

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About this study

This study was designed to evaluate if patients with hypertension treated early with a combination therapy would achieve better blood pressure (BP) control, than patients being treated with a classical sequential add-on therapy.

The study compared the effects of the two treatment strategies: Treatment initiation on a single compound, either with aliskiren or amlodipine, and then continuation with the combination of both versus treatment initiation with the combination of aliskiren/amlodipine and then continuation with the combination. The study also evaluated if the overall mean sitting systolic blood pressure (msSBP)-lowering effect during the study, as well as the change from baseline to study end in msSBP, are superior in the group having received combination therapy from the beginning.

The study further evaluated the BP-lowering efficacy and tolerability of both treatment strategies.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female outpatients ≥ 18 years of age
  • Participants with essential hypertension:
  • Naive participants must have a mean sitting Systolic Blood Pressure (msSBP) ≥ 150 mmHg and < 180 mmHg at Visit 1 and Visit 2. (Participants are considered 'naïve' if they have never been treated with any antihypertensive medication.)
  • All participants must have a msSBP ≥ 150 mmHg and < 180 mmHg at Visit 2
  • Written informed consent to participate in this study prior to any study procedures

Exclusion criteria

  • Severe hypertension
  • Pregnant or nursing (lactating) women
  • Pre-menopausal women not taking accepted form of birth control
  • Serum potassium ≥ 5.5 mEq/L (mmol/L) at Visit 1
  • History of cardiovascular conditions
  • Uncontrolled Type 1 or Type 2 diabetes mellitus
  • Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with similar chemical structures

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

Amlodipine

Drug

Amlodipine (5 mg and 10 mg) was provided as capsules taken orally once daily.

Other names: Norvasc

Hydrochlorothiazide

Drug

Hydrochlorothiazide 12.5 mg capsules were taken orally once daily

Other names: Esidrix, HydroDIURIL, Oretic, Ezide, Hydro-Par

Aliskiren

Drug

Aliskiren 150 mg and aliskiren 300 mg were provided as film-coated tablets, taken orally once daily.

Other names: SPA 100

Primary outcomes

  1. Overall Mean Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Over 8, 16 and 24 Weeks

    Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks

    Systolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msSBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures Analysis of Covariance (ANCOVA) model with treatment, visit, and region as factors, treatment by visit interaction and baseline msSBP as a covariate.

  2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 24

    Time frame: Baseline to 24 weeks

    Systolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region as factors, treatment by visit interaction and baseline msSBP as a covariate.

Secondary outcomes

  1. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 32

    Time frame: Baseline to 32 weeks

    Diastolic Blood Pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 32 weeks of study treatment. Change at Week 32 used a separate repeated measures ANCOVA model containing Week 8, 16, 24 and 32 data. Treatment, visit and region were factors in the model, treatment by visit interaction and baseline msDBP a covariate.

  2. Overall Mean Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Over 8, 16, and 24 Weeks

    Time frame: Baseline, 8 weeks, 16 weeks and 24 weeks

    Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and over 8, 16 and 24 weeks of study treatment. The overall mean change in msDBP from baseline was estimated over three time points: Week 8, Week 16, and Week 24. Analysis used a repeated measures ANCOVA model with treatment, visit and regions as factors, treatment by visit interaction and baseline msDBP as a covariate.

  3. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 24

    Time frame: Baseline to 24 weeks

    Diastolic Blood pressure was measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and 24 weeks of study treatment. Analysis used a repeated measures ANCOVA model with treatment, visit and region, as factors, treatment by visit interaction and baseline msDBP as a covariate.

  4. Percentage of Participants Achieving Overall Blood Pressure Control at 8, 16, 24 and 32 Weeks Endpoints

    Time frame: Baseline to week 8, 16, 24 and 32 endpoints

    Systolic & Diastolic Blood Pressure were measured in a sitting position using a validated automated blood pressure monitor (the Omron device) according to Guidelines of the British Hypertension Society, at Baseline and after 8, 16 , 24 and 32 weeks. Outcome is reported as percentage of participants achieving overall blood pressure control (msSBP <140 mmHg and msDBP <90 mmHg) at weeks 8, 16, 24 & 32 endpoints.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Randomized, 32 Week Double-blind, Parallel-group, Multicenter Study to Compare the Efficacy and Safety of Initiating Treatment With Combination (Aliskiren/Amlodipine) Therapy in Comparison With the Sequential add-on Treatment Strategies in Patients With Essential Hypertension

Acronym: ACCELERATE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2008
Registry last updated
Oct 17, 2011

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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