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Efficacy and Safety of the Combination Aliskiren (300 mg) and Hydrochlorothiazide (25mg) to Aliskiren (300mg) Monotherapy in Patients With Staged II Hypertension (ACQUIRE)

24 mai 2011 mis à jour par: Novartis

A 12 Week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Hydrochlorothiazide 25 mg Compared to Aliskiren 300 mg in Patients With Stage II Hypertension

This study will compare the efficacy and safety of once daily dosing of aliskiren monotherapy to once daily dosing of aliskiren and hydrochlorothiazide combination therapy in patients with Stage II hypertension over a period of 12 weeks.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

688

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Allemagne
      • Berlin, Allemagne
        • Investigative Site
  • Argentine
      • Buenos Aires, Argentine
        • Investigative Site
  • Equateur
      • Quito, Equateur
        • Investigative Site
  • Guatemala
      • Guatemala City, Guatemala
        • Investigative Site
  • Italie
      • Rome, Italie
        • Investigative Site
  • Suisse
      • Basel, Suisse
        • Investigative Site
  • Turquie
      • Ankara, Turquie
        • Investigative Site
  • États-Unis
    • New Jersey
      • East Hanover, New Jersey, États-Unis, 07936
        • Investigative Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Outpatients ≥18 years of age.
  • Patients with a diagnosis of Stage II hypertension, defined as mean sitting Systolic Blood Pressure (msSBP) ≥ 160 mmHg and < 180 mmHg at Visit 2.

Exclusion Criteria:

  • Severe hypertension defined as msSBP ≥ 180 mmHg and/or mean sitting Diastolic Blood Pressure (msDBP) ≥ 110 mmHg.
  • Secondary form of hypertension.
  • Current diagnosis of heart failure (New York Heart Association [NYHA] Class II-IV).
  • Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates).
  • Second or third degree heart block without a pacemaker.
  • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1.
  • Clinically significant valvular heart disease.
  • Previous history of hypertensive encephalopathy or stroke, Transcient Ischemic Attack (TIA), heart attack, coronary bypass surgery or any PCI.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • In the month prior to Visit 1, patients on combination antihypertensive therapy that includes more than 2 classes of antihypertensive medications.
  • Patients on combined antihypertensive medication that contain two classes of antihypertensive medications are considered to take two antihypertensive medications.
  • Inability to discontinue prior antihypertensive or other CV medications as required by the protocol.
  • Patients with Type 1 diabetes mellitus.
  • Patients with Type 2 diabetes mellitus not well controlled .
  • Elevated Serum potassium (over 5.3 mEq/L (mmol/L).
  • Any surgical or medical condition or the use of any medication which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

Other protocol-defined inclusion/exclusion criteria may apply.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
Médicament: Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)
During the titration period, patients received aliskiren/hydrochlorothiazide (HCTZ) 150/12.5 mg for 1 week.
Comparateur actif: Aliskiren (300 mg)
Médicament: Aliskiren (300 mg)
During the titration period, patients received aliskiren 150 mg for one week. Subsequently, patients were up-titrated and received aliskiren 300 mg.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 12)
Délai: Baseline to end of study (Week 12)
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Baseline to end of study (Week 12)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 8
Délai: Baseline to Week 8
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Baseline to Week 8
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 8 and to Week 12
Délai: Baseline to Week 12
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Baseline to Week 12
Percentage of Patients Achieving the Target Blood Pressure (msSBP < 140 mm Hg and msDBP < 90 mm Hg, and msSBP < 130 mm Hg and msDBP < 80 mm Hg for Diabetics) at Week 8 and Week 12
Délai: Baseline to Week 12
At the first visit, blood pressure (BP) was measured in both arms and the arm having the higher BP reading was the arm used for all subsequent readings throughout the study. Patients were required to sit for five minutes with feet flat on the floor, with arm resting so that the bottom of the cuff was at the same level as the heart. BP was measured three times at 1 to 2-minute intervals at each visit using the correct cuff size. The mean BP was calculated from the 3 readings.
Baseline to Week 12

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Novartis

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2008

Achèvement primaire (Réel)

1 avril 2009

Achèvement de l'étude (Réel)

1 avril 2009

Dates d'inscription aux études

Première soumission

23 juin 2008

Première soumission répondant aux critères de contrôle qualité

25 juin 2008

Première publication (Estimation)

26 juin 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

30 mai 2011

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2011

Dernière vérification

1 mai 2011

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • CSPP100A2353

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Hypertension

Essais cliniques sur Aliskiren/hydrochlorothiazide (HCTZ) (300/25 mg)

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Conditions

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Commanditaire / collaborateurs

Emplacements

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