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A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

A 28 to 54-week, Open-label, Multicenter Study to Assess the Long-term Safety and Tolerability of the Combination of Aliskiren / Amlodipine / Hydrochlorothiazide in Patients With Essential Hypertension

NCT00667719•Novartis

View on ClinicalTrials.gov

Summary

This study tested the safety of the combination of aliskiren/amlodipine/hydrochlorothiazide in participants with essential hypertension.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Outpatients 18 years of age or older
•Male or female participants are eligible.
•Mean sitting diastolic blood pressure (msDBP) and mean sitting systolic blood pressure (msSBP) Requirements:
•* For newly diagnosed/untreated participants, msDBP ≥ 100 and \< 120 millimeters of mercury (mmHg), and/or msSBP ≥ 160 and \< 200 mmHg at Visit 1 and Visit 2.
•* For previously treated participants, msDBP ≥ 100 and \< 120 mmHg, and/or msSBP ≥ 160 and \< 200 mmHg at Visit 2, Visit 3, or Visit 4.
•For participants requiring tapering off their previous antihypertensive medication, they must meet the above criteria and completely discontinue all antihypertensive treatment prior to entering the treatment phase of the study.
•Participants who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).

Exclusion Criteria

•Inability to discontinue all prior antihypertensive medications safely for a period of 1 week to 4 weeks as required by the protocol.
•Participants on three antihypertensive drugs with msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg at Visit 1.
•Participants on four or more antihypertensive drugs at Visit 1.
•Participants with an msSBP ≥ 200 and msDBP ≥ 120 mmHg anytime during the washout period of the study Visit 1-4 must be discontinued from the study.
•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\>= 5 milli-international units per milliliter mIU/mL).

Locations (8)

Investigative Site

Houston, Texas, United States

Investigative Site

Belgium, Belgium

Investigative Site

Egypt, Egypt

Investigative Site

Germany, Germany

Investigative Site

Poland, Poland

Investigative Site

Slovakia, Slovakia

Investigative Site

Spain, Spain

Investigative Site

Turkey, Turkey (Türkiye)

Key Dates

Start Date

June 5, 2008

Primary Completion Date

October 5, 2009

Completion Date

October 5, 2009

Last Updated

June 7, 2021

Enrollment

564

ACTUAL participants

Conditions

Essential Hypertension

Interventions

Aliskiren

DRUG

Amlodipine

DRUG

Hydrochlorothiazide

DRUG

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

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Healthy Volunteers Essential Hypertension

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Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

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COMPLETEDPHASE3

PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NIFEDIPINE 30MG EXTENDED-RELEASE IN ADULT PATIENTS DIAGNOSED WITH MILD OR MODERATE HYPERTENSION IN COLOMBIA.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Long Term Safety Study to Test the Combination of Aliskiren/ Amlodipine / Hydrochlorothiazide in Participants With Essential Hypertension

Inclusion Criteria

Exclusion Criteria

Study of KK3910 in Healthy Volunteers and Patients With Essential Hypertension

Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension

PHASE III, RANDOMIZED, ACTIVE-COMPARATOR CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF NIFEDIPINE 30MG EXTENDED-RELEASE IN ADULT PATIENTS DIAGNOSED WITH MILD OR MODERATE HYPERTENSION IN COLOMBIA.

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