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Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II Hypertension

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage II Hypertension

Intervention: Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study assessed the efficacy and safety of combination therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in patients with stage II Hypertension.

Clinical Details

Official title: Multi-center, Open Label, 18-week Study to Demonstrate the Efficacy and Safety of Combination Therapy of Aliskiren/Amlodipine or Aliskiren/Amlodipine/Hydrochlorothiazide in Patients With Stage II HT

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of participants with stage II hypertension achieving blood pressure (BP) goal

Secondary outcome:

Percentage of participants who have blood pressure surge to their baseline level during 24-h ambulatory blood pressure monitor (ABPM)

Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to study end

Number of participants with responder rate for Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP)

Number of patients with any adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Outpatients 18 years of age or older

- Male or female patients are eligible. Female patients must be either post-menopausal

for one year, surgically sterile, or using effective contraceptive methods such as oral contraceptives, barrier method with spermicidal or an intrauterine device.

- Patients with a diagnosis of hypertension as following msDBP & msSBP Requirements:

- For newly diagnosed/untreated patients:

- Mean Sitting Diastolic Blood Pressure (msDBP) ≥ 100 and < 120 mmHg, and/or

mean sitting Systolic Blood Pressure (msSBP) ≥ 160 and < 200 mmHg at Visit1.

- For previously treated patients with 1 or 2 antihypertensive medications:

- msDBP ≥ 90 and < 100 mmHg, and/or msSBP ≥ 140 and < 160 mmHg at Visit 1 AND

- msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg at Visit 2.

- For previously treated patients with Atenolol 50 mg once daily alone more than 2

weeks consecutively at visit 1:

- msDBP ≥ 100 and < 120 mmHg, and/or msSBP ≥ 160 and < 200 mmHg.

- Patients 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:

- Patients that previously participated in any Aliskiren study.

- Inability to receive or completely replace all previous antihypertensive medications

with Atenolol 50 mg once daily for a period of 2 weeks as required by the protocol.

- Patients on 1 (other than Atenolol 50 mg once daily) or 2 antihypertensive drugs with

msDBP ≥ 100 mmHg and/or msSBP ≥ 160 mmHg at Visit 1.

- Patients on 3 or more antihypertensive drugs at Visit 1.

- Pregnant or nursing (lactating) women, when pregnancy is defined as the state of a

female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (≥ 5 mIU/mL).

- Sexually active female patients who are not using effective contraceptive methods.

- Serum potassium <3. 5 mEq/L (mmol/L) or > 5. 5 mEq/L at Visit 1.

- Second or third degree heart block with or without a pacemaker, or other potentially

life-threatening or symptomatic arrhythmia current or by history.

- History of noncompliance to medical regimens or unwillingness to comply with the

study protocol. Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Investigative Site, Bangkok, Thailand

Investigative Site, Chiang Mai, Thailand

Investigative Site, Nakhon Ratchasima, Thailand

Additional Information

Starting date: January 2010
Last updated: December 5, 2013

Page last updated: August 23, 2015

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