Clinical trial NCT00523744: Efficacy and Safety of Valsartan and Amlodipine (± HCTZ) in Adults With Moderate, Inadequately Controlled Hypertension
Official title: An Open-label, Multicenter Study to Evaluate the Efficacy and Tolerability of a 4 Week Therapy With the Fixed Dose Combination of Amlodipine 10 mg Plus Valsartan 160 mg in Hypertensive Patients Not Adequately Responding to a 4 Week Therapy With the Free Combination of an Angiotensin Receptor Blocker (Olmesartan 20 mg) Plus Amlodipine 10 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension, valsartan, amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of valsartan and amlodipine in fixed dose combination in adults with moderate, inadequately controlled hypertension. There was an optional study extension for eligible patients who wanted to participate that contains the triple therapy (ie, hydrochlorothiazide+ amlodipine/valsartan).

Detailed description: Title of study extension: An open-label, multicenter extension to evaluate the efficacy and tolerability of a 4 week therapy with hydrochlorothiazide 12.5 mg plus amlodipine 10 mg/valsartan 160 mg in hypertensive patients not adequately responding to a 4 week therapy each with the combinations of olmesartan 20 mg plus amlodipine 10 mg followed by amlodipine 10 mg/valsartan 160 mg

Eligibility criteria: Inclusion Criteria for Core study:

* Male or female patients (\>=18 years)
* Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods
* Patients with essential hypertension (diastolic blood pressure \>=100 mmHg and \<110 mmHg)

Inclusion Criteria for Extension:

- Patients had to have a msSBP \>= 140 mmHg and/or msDBP \>= 90 mmHg at week 8 ie, end of core study.

Exclusion Criteria for Core study:

* Severe hypertension (diastolic blood pressure \>=110 mmHg or systolic blood pressure \>= 180 mmHg)
* Pregnant or nursing women
* Treated hypertensive patients with controlled hypertension under current therapy
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV

Exclusion Criteria for Extension:

* prematurely discontinued the core study
* failed to comply with the core study protocol

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Core Phase of the Study
timeFrame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
measure: Change in Mean Sitting Diastolic Blood Pressure (msDBP) During the Extension Phase of the Study
timeFrame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
Secondary outcomes:
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Core Phase of the Study
timeFrame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
measure: Change in Sitting Pulse Pressure During the Core Phase of the Study
timeFrame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
measure: Change in Sitting Pulse Rate During the Core Phase of the Study
timeFrame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
measure: Percentage of Patients Who Achieved Normalized Blood Pressure During the Core Phase of the Study
timeFrame: Baseline Phase 2 (Week 4) to end of Phase 2 (Week 8)
measure: Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Core Phase of the Study
timeFrame: Baseline of Phase 2 (Week 4) to end of Phase 2 (Week 8)
measure: Change in Mean Sitting Systolic Blood Pressure (msSBP) During the Extension Phase of the Study
timeFrame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
measure: Change in Sitting Pulse Pressure During the Extension Phase of the Study
timeFrame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
measure: Change in Sitting Pulse Rate During the Extension Phase of the Study
timeFrame: Baseline Phase 3 (Week 8) to end of Phase 3 (week 12)
measure: Percentage of Patients Who Achieved Normalized Blood Pressure During the Extension Phase of the Study
timeFrame: Baseline Phase 3 (Week 8) to end of Phase 3 (Week 12)
measure: Percentage of Patients Who Achieved a Protocol-defined Blood Pressure Response During the Extension Phase of the Study
timeFrame: Baseline of Phase 3 (Week 8) to end of Phase 3 (Week 12)
Other outcomes:
Locations:
city: Schwerin
country: Germany
facility: Novartis Investigative Site, , Germany
facility: 30 sites in Germany
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: