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

Purpose

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

Condition	Intervention	Phase
Stage II Hypertension	Drug: Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day)	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Hydrochlorothiazide Amlodipine Amlodipine besylate Aliskiren

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage of participants with stage II hypertension achieving blood pressure (BP) goal [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
The BP goal for non-diabetic patient is defined as msSBP < 140 mmHg and msDBP < 90 mmHg. The BP goal for diabetic patient is msSBP < 130 mmHg and msDBP < 80 mmHg) in patients with stage II hypertension.

Secondary Outcome Measures:

Percentage of participants who have blood pressure surge to their baseline level during 24-h ambulatory blood pressure monitor (ABPM) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
24-h ABPM profiles were assessed by percentage of participants who have blood pressure (BP) surge to their baseline level (during 24-h ABPM) once after patients achieve BP goal (BP goal for non-diabetic patient is defined as msSBP < 140 mmHg and msDBP < 90 mmHg; and the BP goal for diabetic patient is msSBP < 130 mmHg and msDBP < 80) at any visit only in selected study sites. The mean 24-hour MADBP (Mean Ambulatory Diastolic Blood Pressure) or MASBP (Mean Ambulatory Systolic Blood Pressure) is defined as the average of the hourly MADBP or MASBP over 24 hours respectively.
Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to study end [ Time Frame: From baseline to study completion (between week 8 to 18) ] [ Designated as safety issue: No ]
mSBP and mDBP is defined as an average of 2 points blood pressure measurements which 5 minutes apart. Patient must be at rest for at least 5 minutes in sitting position before the heart rate and blood pressure measurement. The arm for blood pressure measurement should be the same during the whole study.
Number of participants with responder rate for Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
The responder rate of msSBP is defined as msSBP < 140 mmHg for non-diabetic patients (msSBP < 130 mmHg for diabetic patients) or by a reduction of ≥ 20 mmHg BP from baseline.

The responder rate of msDBP is defined as msDBP < 90 mmHg for non-diabetic patients ( msDBP < 80 mmHg for diabetic patients) or by a reduction of ≥ 10 mm Hg BP from baseline
Number of patients with any adverse events [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not considered related to the medicinal (investigational) product.


Enrollment:	230
Study Start Date:	January 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Intervention Details:

The patients were asked for 2 week run-in phase with atenolol 50 mg qd(once a day), followed by 4 schedule visits with 4-week interval until patient achieved BP goal. The maximum follow up was 16-week treatment. At visit 2, the patients started receiving Aliskiren/Amlodipine (150/5mg per day) for 4 weeks. At visit 3, if the patients did not achieve blood pressure (BP) goal, patients were up titrated to Aliskiren/Amlodipine (300/10 mg/day) for 4 weeks. At visit 4, if the patients did not achieve BP goal, HCT 12.5 mg/day was added to Aliskiren/Amlodipine/HCT (300/10/12.5 mg/day) for 4 weeks. Finally at visit 5, if the patients did not achieve BP goal, HCT was up titrated to Aliskiren/Amlodipine/HCT (300/10/25 mg/day) for 4 weeks until visit 6. Once the patients achieved BP goal at any visit, they completed the study.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070030

Locations


Thailand
Investigative Site
Bangkok, Thailand
Investigative Site
Chiang Mai, Thailand
Investigative Site
Nakhon Ratchasima, Thailand

Sponsors and Collaborators

Novartis

Investigators


Study Director:	Novartis Pharmaceuticals	Novartis Pharmaceuticals

More Information


Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT01070030 History of Changes
Other Study ID Numbers:	CSPP100ATH01
Study First Received:	February 16, 2010
Last Updated:	December 5, 2013
Health Authority:	Thailand: Ethical Committee

Keywords provided by Novartis:


Stage II Hypertension, Aliskiren, Amlodipine, Hydrochlorothiazide

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Hydrochlorothiazide Antihypertensive Agents Calcium Channel Blockers	Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Diuretics Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors

ClinicalTrials.gov processed this record on September 28, 2016

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