Comparison of Tandospirone, Amlodipine and Their Combination in Adults With Hypertension and Anxiety

NCT03667677 | Unknown Phase 4

• 1 other identifier: CES-TAHA
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 7

Brief Summary

This study compares the antihypertensive effects between different treatment groups including antihypertensive drug, anxiolytic, and both, which provide a new clinical evidence for controlling blood pressure in patients with hypertension and anxiety.

Conditions

Hypertension; Anxiety

Keywords

Hypertension; Anxiety; Tandospirone; Amlodipine

Outcome Measures

Primary Outcomes (2)

• Office systolic blood pressure and diastolic blood pressure

  Change from Baseline Office systolic blood pressure and diastolic blood pressure at 4 weeks and 8 weeks

• 14-item Hamilton Anxiety Scale(HAMA)

  HAMA-14 are rated on 5 grades ranging from 0(no symptom) to 4 (very severe). The total score ranges from 0 to 56. 29 or more on HAMA means severe anxiety disorders, 21 to 28 on HAMA means obvious anxiety disorders, 14 to 20 on HAMA means anxiety disorders, 8 to 13 on HAMA means suspicious anxiety disorders, 7 or less means no anxiety disorders.

  Change from Baseline HAMA score at 4 weeks and 8 weeks

Secondary Outcomes (9)

• the proportion of patients who met blood pressure control goal( < 140/90mmHg)

  Week 8

• 24-hour ambulatory blood pressure monitoring(ABPM)

  Change from Baseline ABPM at 4 weeks and 8 weeks

• the proportion of participants with an at least 50% reduction of HAMA score from baseline

  Week 8

• the proportion of participants showing 7 or less on HAMA

  Week 8

• 20-item Self-Rating Anxiety Scale(SAS)

  Change from Baseline SAS score at 4 weeks and 8 weeks

Study Arms (4)

Group 1

EXPERIMENTAL

Tandospirone + Amlodipine

Drug: Tandospirone + Amlodipine

Group 2

EXPERIMENTAL

Tandospirone placebo + Amlodipine

Drug: Tandospirone placebo + Amlodipine

Group 3

EXPERIMENTAL

Tandospirone + Amlodipine placebo

Drug: Tandospirone + Amlodipine placebo

Group 4

PLACEBO COMPARATOR

Tandospirone placebo + Amlodipine placebo

Drug: Tandospirone placebo + Amlodipine placebo

Interventions

Tandospirone + Amlodipine DRUG

The first group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).

Group 1

Tandospirone placebo + Amlodipine DRUG

The second group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).

Group 2

Tandospirone + Amlodipine placebo DRUG

The third group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).

Group 3

Tandospirone placebo + Amlodipine placebo DRUG

The fourth group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).

Group 4

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An age of 60 - 80 years old;
• Mild or moderate hypertension diagnosed in previous or at screening (office systolic blood pressure ≥ 140 mm Hg and ≤ 180 mm Hg, or diastolic blood pressure ≥ 90 mm Hg and ≤ 110 mm Hg, or both, on three readings on separate days when not taking any blood pressure drugs) ,and the blood pressure still meet the above criteria after the run-in period;
• A total score ≥ 14 and ≤ 24 on the Hamilton Anxiety Scale (HAMA), except for panic disorder;
• Informed consent signed.

You may not qualify if:

• Secondary hypertension;
• Office systolic blood pressure ≥ 180 mm Hg or diastolic blood pressure ≤ 110 mm Hg
• Hypertension with target organ damage;
• Cerebral hemorrhage, ischemic cerebral infarction, coronary artery disease, myocardial infarction, second-degree or third-degree atrioventricular block, sick sinus syndrome, atrial fibrillation, left ventricular hypertrophy, cardiac insufficiency (NYHA class Ⅱ-Ⅳ);
• Diabetes and dyslipidemia;
• Asthma, chronic obstructive pulmonary disease, bronchiectasis, and respiratory failure;
• Inflammatory bowel disease, active gastritis, pancreatitis, partial or complete intestinal obstruction, and chronic diarrhea;
• Acute or chronic hepatitis, hepatic insufficiency (ALT or AST is more than 2 times the upper limit of normal), and renal insufficiency (serum creatinine \> 130 umol / L);
• Uncontrolled thyroid diseases;
• Severe or unstable central nervous system diseases;
• Schizophrenia, bipolar disorder, severe intellectual disability, or severe cognitive impairment;
• Having been diagnosed with alcohol or drug abuse within the past 1 year;
• Presenting the risk of suicide, self-injury, and hurt others;
• Having participated in other clinical studies within the past 3 months;
• Having been treated with anxiolytics, antidepressants, antipsychotics within the past 4 weeks, or have contraindications to the study medications.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (7)

Beijing Friendship Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

Beijing Haidian Section of Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Location

Yongchuan Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

Zhongda Hospital of Southeast University

Nanjing, Giangsu, China

Location

Kailuan General Hospital

Tangshan, Hebei, China

Location

the First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Related Publications (4)

• Bhattacharya R, Shen C, Sambamoorthi U. Excess risk of chronic physical conditions associated with depression and anxiety. BMC Psychiatry. 2014 Jan 16;14:10. doi: 10.1186/1471-244X-14-10.

  PMID: 24433257 BACKGROUND

• Pan Y, Cai W, Cheng Q, Dong W, An T, Yan J. Association between anxiety and hypertension: a systematic review and meta-analysis of epidemiological studies. Neuropsychiatr Dis Treat. 2015 Apr 22;11:1121-30. doi: 10.2147/NDT.S77710. eCollection 2015.

  PMID: 25960656 BACKGROUND

• Byrd JB, Brook RD. Anxiety in the "age of hypertension". Curr Hypertens Rep. 2014 Oct;16(10):486. doi: 10.1007/s11906-014-0486-0.

  PMID: 25164965 BACKGROUND

• Kretchy IA, Owusu-Daaku FT, Danquah SA. Mental health in hypertension: assessing symptoms of anxiety, depression and stress on anti-hypertensive medication adherence. Int J Ment Health Syst. 2014 Jun 21;8:25. doi: 10.1186/1752-4458-8-25. eCollection 2014.

  PMID: 24987456 BACKGROUND

MeSH Terms

Conditions

Hypertension; Anxiety Disorders

Interventions

tandospirone; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Peng Xie

CONTACT

86-023-68485490; xiepeng@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Yongchuan Hospital of Chongqing Medical University

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 12, 2018
• Study Start: February 1, 2019
• Primary Completion: February 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 4, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)